primary outcome:
Rehabilitation following surgery for flexor tendon injuries of the hand
Functional assessment using a patient reported outcome measure, such as Patient Rated Wrist and Hand Evaluation (PRWHE); Michigan Hand Questionnaire (MHQ); or Disability of the Arm, Shoulder and Hand (DASH)Active finger ROM using goniometric measurement. Different classification systems have been designed that incorporate ROM and are used to describe outcomes following tendon surgery (such as, Stickland‐Glogovac classification; Strickland classification; Tang classification)Adverse events including tendon rupture, revision surgery, scar adhesion, delayed wound healing, loss of mobility or function, joint contracture, triggering of the digit, pulley failure, persistent pain and sensory deficits. We will report the total number of participants with adverse events and for each of these eventsFunctional assessment using a patient reported outcome measureThe use of the injured finger(s) in ADL at 2, 3, 6 and 12 month follow‐ups was evaluated using a visual analogue scale (0 to 10; higher scores = better ADL). The Med and IQR results presented in the trial report are shown in Analysis 1.1, and the mean and SD results provided by the trial authors to us are shown, is in Analysis 1.2.There were no significant between‐group differences at any time point reported by the authors. All differences between the two groups were under 1.0 point and thus unlikely to be clinically important.The exploratory analyses in Analysis 1.2 indicated higher scores in the active group at two months, but not subsequently.Active finger range of motionActive range of motion was measured using a goniometer as a continuous outcome. Using the individual PIP and DIP joint measurements of the finger, these were summed to calculate TAM. From these data, Strickland‐Glogovac (Strickland 1980) and Tang (Tang 2007) classifications were calculated (refer to Table 4 for a definition for each of the classifications categories).TAM of PIP and DIP joints (in degrees).No evidence of between‐group differences were found between the two groups at any of the follow‐ups (Analysis 1.3).Strickland classification (number of fingers that were classified as a "poor" category)There were no significant differences between groups at any time interval (Analysis 1.4). Rigo 2017 also found no statistically significant differences in the distribution of participants in the four categories (excellent, good, fair and poor) for active range of motion for the finger digits at 2, 3, 6 or 12 months. The data at 12 months were excellent (20), good (8), fair (5) and poor (1) for the active group and excellent (14), good (6), fair (5) and poor (4) for the control group; reported P = 0.247.Tang classification (number of fingers that were classified as a "failure" or "poor" result (Analysis 1.4).There were no significant differences between groups at any time interval.Adverse eventsOverall, there were six adverse events reported in the active group versus nine adverse events in the control group (RR 0.58, 95% CI 0.23 to 1.44; Analysis 1.5).Tendon ruptureTwo FDP tendon ruptures occurred in the active group at weeks 5 and 6 respectively, whereas one FDP rupture was reported at week 12 in the control group. All ruptures underwent secondary surgery.Complex regional pain syndromeThe only participant developing this adverse outcome was in the control group.Wound dehiscenceDelayed wound healing or superficial infection was seen in six fingers in the control group versus none in the active group.Swelling and tenderness of the tendon sheaf (all transitory)This was seen in four fingers in the active group versus one in the control group.Functional assessment using a patient reported outcome measureNot reportedActive finger range of motionUsing the Strickland classification, the total percentages of participants achieving "good‐excellent" results in the two groups were reported at 8, 12 and 24 weeks. These are shown below. Some of the percentages do not correspond to whole numbers if the numbers randomised (16 versus 19) are used. The authors reported that the study did not show any significant difference in "functional outcome" between the two groups.At 8 weeks (percentage of participants with good or excellent outcomes): 75% active group versus 95% controlled passive group (probably corresponds to 18/19 versus 12/16)At 12 weeks (percentage of participants with good or excellent outcomes): 81% active group versus 94% controlled passive groupAt 24 weeks (percentage of participants with good or excellent outcomes): 92% active group versus 100% controlled passive groupAdverse eventsThese were not reported. However, subsequent surgery required in eight participants comprised five tenolysis, one DIP fusion and two flexor tendon grafts due to late rupture. No breakdown was provided by treatment group.Functional assessment using a patient reported outcome measureNot reported.Active finger range of motionTAM for the digits (numbers in each group not reported)Scavenius 2000 reported that there was no significant difference between the two groups in mean TAM as a percentage of normal values: active group was 70.1% compared with the passive group at 75.7%.Strickland classificationScavenius 2000 reported the differences in the percentages of participants in the four categories (excellent, good, fair and poor) for active range of motion for the finger digits was not significant. Data for the two groups were for excellent (25%), good (8%), fair (67%) and poor (0%) for the active group and excellent (27%), good (33%), fair (40%) and poor (0%) for the passive group.Active thumb IP joint motion (numbers in each group not reported)Scavenius 2000 reported the mean range of motion for the repaired thumb tendons was 51.7 degrees in the active group and 66.7 degrees in the passive group (between group difference reported as not significant: reported P = 0.7).Adverse events.Adverse events were recorded for each group were the number of participants who experienced a tendon rupture and the number of participants with scar adhesions that required surgery (tenolysis surgical procedure). Data for these are presented Analysis 2.1.Tendon ruptures. All three tendon ruptures occurred in the active group.Tenolysis surgery was required for four participants in the active group and two participants in the passive group.Functional assessment using a patient reported outcome measureNot reported.Active finger range of motionTAMThe median range of motion was 245 degrees in the early active group versus 250 degrees in the controlled passive group. The authors stated there was no statistically significant difference between the groups.DIP active motionThe median active motion was 65 degrees in the active group and 58 degrees in the controlled passive group. The authors stated there was no statistically significant difference between the groups.Adverse eventsTendon rupturesThere were 13 tendon ruptures overall, five of which occurred in the active group and eight in the controlled passive group.Extension deficit of the DIP joint.The median extension deficit was 5 degrees in both groups.Functional assessment using a patient reported outcome measureNot reported.Active finger range of motionOnly the number of participants for each of the IFSSH or Strickland classification groups were reported. For the analysis, we present the numbers in the poor categories of the two outcomes. At 12 months or more post‐surgery, the active exercise group had fewer poor outcomes than the immobilisation group when rated using either the IFSSH (1/37 versus 15/47; RR 0.08, 95% CI 0.01 to 0.61) or Strickland's classification (0/37 versus 7/47; RR 0.08, 95% CI 0.00 to 1.43; very low‐certainty evidence); seeAnalysis 3.1.Trial authors reported that according to the IFSSH classification (% of participants in this category(number of digits)):Active exercise group: excellent 0% (n = 0); good 65% (n = 24); satisfactory 32% (n = 12); poor 3% (n = 1).Immobilisation group: excellent 0% (n = 0); good 43% (n = 20); satisfactory 25% (n = 12); poor 32% (n = 15).Trial authors reported the following according to the Strickland's classification (% of participants in this category(number of digits)):Active exercise group: excellent 62% (n = 23); good 35% (n = 13); satisfactory 3% (n = 1); poor 0% (n = 0).Immobilisation group: excellent 47% (n = 22); good 23% (n = 11); satisfactory 15% (n = 7); poor 15% (n = 7).Adverse eventsThe overall number of participants experiencing one or more adverse events was not reported.Tendon ruptures was reported in 13.5% of the participants in the active group (5 of 37 participants), all of which occurred in the second week after commencing active mobilisation (Analysis 3.2). All participants underwent immediate surgical rerepair performed in the same way as the primary tendon suture and were returned to the early active exercise regimen. No participants in the Immobilisation group experienced a tendon rupture.Tenolysis surgery was not required by participants in the active group compared with 21% participants (10 of 47 participants) of the immobilisation group, whose range of motion deficit fulfilled the indication criterion for tenolysis (Analysis 3.2). However, it is not clear whether these went on to have tenolysis.Actual or indicated secondary surgery for tendon rupture or a range of motion deficit indicating scar adhesionsSecondary surgery was either tendon repair in the active group or indication for tenolysis in the immobilisation group (5/37 versus 10/47; RR 0.64, 95% CI 0.24 to 1.70; very low‐certainty evidence; Analysis 3.2).Functional assessment using a patient‐reported outcome measureNot reported.Active finger range of motionData for active ROM was reported as a percentage difference in mean values of TAM between the 12 week and initial measurement at four weeks, and reported for individual digits (i.e. index, middle, ring and small digit data were reported separately). Requests to the trial authors for more information, including final ROM data, were unsuccessful.Adverse eventsOnly tendon rupture was reported; there were none in either group.Functional assessment using a patient reported outcome measure (DASH score, 0 to 100 with a higher score indicating more disability); see Analysis 5.1.This was reported in two trials but at different times (6 months and 12 months).Reflecting the non‐normal distribution of the results, Abdel Sabour 2018 reported Med and IQR and found no evidence of a difference between the two groups at six months: place and hold group Med 23, IQR 2 to 26; passive group Med 15, IQR 10 to 30; reported P = 0.62. They also reported mean and standard deviations in their discussion, which are shown in an exploratory analysis, again showing no evidence of a difference between the two groups (MD ‐1.10, 95% CI ‐14.44 to 12.24; 26 participants; very low‐certainty evidence; downgraded one level for serious risk of bias and two levels for very serious imprecision).Trumble 2010 found no important difference in function between the two groups at one year (MD ‐1.10, 95% CI ‐2.77 to 0.57; 89 participants; very low‐certainty evidence; downgraded two levels for very serious risk of bias and one level for imprecision, reflecting potential ceiling effects given the very low DASH scores indicating minimal upper limb disability).Active finger range of motion; see Analysis 5.2Active finger range of motion was reported using a continuous range of motion outcome (TAM) in Abdel Sabour 2018 and Trumble 2010, and also as a dichotomous outcome by categorising the continuous outcome into four categories (Poor; Good; Satisfactory; Excellent) using the Strickland Classification System in Abdel Sabour 2018. Active range of motion was not directly reported in Abdel Sabour 2018 but goniometry data would have been used to assess contracture and deformity (see adverse events).Farzad 2014 found the TAM at PIP and DIP joint was significantly better in the place and hold group compared with the controlled passive group at eight weeks (MD 32.00 degrees, 95% CI 15.5 to 48.5; 64 digits; very low certainty evidence).Trumble 2010 found greater active range of motion in the place and hold group at 6, 12, 26 weeks and, as shown in Analysis 5.2, at 52 weeks: MD 28.00 degrees, 95% CI 18.87 to 37.13; 102 digits; very low certainty evidence). The number of participants or digits included in the analyses for the 6, 12 and 26 week time points were not reported.In Farzad 2014, no digits in the place and hold group had a "poor" outcome according to the Stickland classification system compared with nine in the controlled passive group at eight weeks (0/31 versus 9/33; RR 0.06, 95% CI 0.00 to 0.92; Analysis 5.3). The numbers of digits in each category were as follows: place and hold group: excellent: 45% (n = 14); good 32% (n = 10); satisfactory 23% (n = 7); poor 0% (n = 0); controlled passive group: excellent: 24% (n = 8); good 18% (n = 6); satisfactory 30% (n = 10); poor 27% (n = 9).Adverse eventsThe available data for these, reported by tendons (digits) rather than participants, are presented in Analysis 5.4. There were no data for overall numbers of participants incurring one or more adverse events. Only Abdel Sabour 2018 reported on adverse events other than tendon rupture.Three tendon ruptures were reported for Abdel Sabour 2018, none in Farzad 2014 and four in Trumble 2010. There was no evidence of a difference between groups (3/96 participants or tendons versus 4/100; RR 0.81, 95% CI 0.19 to 3.50; 196 participants). All four participants in Trumble 2010 underwent surgery to re‐repair the tendons using a two‐stage surgical reconstruction; they were all excluded from final analysis.Abdel Sabour 2018 reported no tendons had scar adherence in the place and hold group compared with 14 in the controlled passive group (0/16 versus 14/20; RR 0.04, 95% CI 0.00 to 0.66). Specific criteria for assessing scar adherence were not provided in this study and it is unclear whether further intervention was undertaken.Abdel Sabour 2018 measured flexion contracture at DIP joint and PIP joint and then as a combined DIP + PIP joint measure. The results probably applied to follow‐up at six weeks.There were fewer DIP joint contractures in the place and hold group: 1/16 versus 10 of 20 tendons (RR 0.13, 95% CI 0.02 to 0.88); as well as fewer PIP joint contractures in the place and hold group (3/16 versus 8/20; RR 0.47, 95% CI 0.15 to 1.48). Abdel Sabour 2018 reported significantly lower combined DIP and PIP flexion deformity, measured in degrees, at six weeks in the place and hold group but we are unsure of these data and have not reported these here. Although assessed in Trumble 2010, data for flexion contractures were not reported.Tendon lag was calculated in Abdel Sabour 2018 by measuring the difference between the passive and active range of motion at the PIP joint and DIP joint to calculate the FDS and FDP tendon lag respectively. Presence of a lag was reported (number of patients with lag as a percentage of participants in that group). Tendon lag is generally reported as an arc of motion (in degrees).There were fewer digits with FDP tendon lag in the place and hold group (2/16 versus 15/20; RR 0.25, 95% CI 0.06 to 0.98) as well as there were fewer digits with FDS tendon lag (2/16 versus 10/20; RR 0.17, 95% CI 0.04 to 0.62).Functional assessment using a patient reported outcome measureNot reported.Active finger range of motionThe authors reported that there was no statistical significance difference in outcome between the two groups (P > 0.05).Adverse eventsNot reported.Functional assessment using a patient‐reported outcome measureSubjective assessment of function, which was measured using a participant's subjective assessment of their own hand function using a visual analogue scale, was equivalent in both groups with a mean value of 88%.Active finger range of motionComparison between the two groups of active ROM was recorded by the trial authors using three different classification scales, none of which are relevant to our review, as they do not rely solely on goniometric measurement. However, Adolfsson 1996 found no significant differences between the groups at any time interval.Adverse eventsTendon ruptureOne FDP tendon in the 8‐week group ruptured at seven weeks after the repair; no tendons ruptured in the 10‐week group (Analysis 6.1).Functional assessment using a patient reported outcome measureThe DASH score was used to measure function and disability. This score ranges from 0 to 100 with a higher score indicating more disability.Whilst both groups improved over time, there is very low‐certainty evidence of no clinically important between‐group differences at either 12 weeks (MD ‐2.80, 95% CI ‐7.63 to 2.03; 59 participants) or 18 weeks (MD ‐0.70, 95% CI ‐4.53 to 3.13); see Analysis 7.1.Active finger range of motionIsolated PIP joints and the DIP joints (as well as MCP joints, which are not the focus of this review) of the affected finger were measured and reported. These measurements were summed to calculate TAM of the affected finger.These measurements were also used to categorise the participants into four outcome groups (Poor; Fair; Good; Excellent) according to the Strickland classification (Strickland 2005).PIP joint active finger range of motion: there is very low‐certainty evidence of little or no between‐group difference in this outcome at any time interval (Analysis 7.2).DIP joint active finger range of motion: there is very low‐certainty evidence of little or no between‐group difference in this outcome at any time interval (Analysis 7.3).TAM of the affected finger: there is very low‐certainty evidence of little or no between‐group difference in this outcome at any time interval (Analysis 7.4).None of the participants in either group had a poor rating according to the Strickland classification at 18 weeks post‐surgery. In the exoskeleton group, the results were: excellent 80% (n = 24); good 18% (n = 5); satisfactory 3% (n = 1); poor 0% (n = 0). In the physiotherapy group, the results were: excellent 62% (n = 18); good 17% (n = 5); satisfactory 20% (n = 6); poor 0% (n = 0).Adverse eventsThree types of adverse events were recorded: tendon ruptures, diagnosis of complex regional pain syndrome (CRPS) and extension deficit. Data for the first two outcomes are shown in Analysis 7.5.One participant of the physiotherapy group suffered a tendon rupture.One participant of the exoskeleton group was diagnosed with CRPS at six weeks.The number of participants with extension deficit at the PIP joint was not stated. This outcome was reported only as a continuous outcome (degrees of deficit).Functional assessment using a patient‐reported outcome measureNot reported.Active finger range of motionTAM was calculated by summing the total active motion of the MCP, PIP and DIP joints at six months post‐surgery. This was then used to categorise participants into groups according to the Strickland‐Glogovac classification (see below).There is very low certainty evidence of higher TAM values in the CPM group (MD 20.48 degrees, 95% CI 0.89 to 40.07; 59 digits; Analysis 8.1).Fewer digits in the CPM group had a poor outcome according to the Strickland‐Glogovac classification (1/29 versus 8/30; RR 0.13, 95% CI 0.02 to 0.97; Analysis 8.2). The data for each of the categories are detailed below:CPM group (% of the entire group in this category(number of digits)): excellent 35% (n = 10); good 31% (n = 9); fair 31% (n = 9); poor 3% (n = 1).Controlled passive group (% of the entire group in this category(number of digits)): excellent 27% (n = 8); good 23% (n = 7); fair 23% (n = 7); poor 27% (n = 8).Adverse eventsGelberman 1991 reported on tendon rupture and infections for each group (Analysis 8.3).One participant in the controlled passive group ruptured both FDP and FDS tendons at four weeks post‐surgery and underwent immediate secondary surgery. His data were not included in the final analysis.No infections occurred in either group.Functional assessment using a patient reported outcome measureNot reported.Active finger range of motionChange in active ROM between three weeks and three months (PIP and DIP ROM combined), which was reported separately for the three ultrasound groups and control group, was presented as the summed mean totals of combined PIP and DIP joint flexion range or motion (TAM). These are entered into RevMan 5 as three subgroups. We split the numbers of the control group into three in order to provide a pooled estimate for this outcome, which favours ultrasound: MD 26.47 degrees, 95% CI 19.70 to 33.24; 131 digits; Analysis 9.1Trial authors reported that according to the Strickland's classification (% of participants in this category(number of digits)):Ultrasound (91 digits): excellent 20% (n = 18); good 57% (n = 52); fair (satisfactory) 5% (n = 5); poor 18% (n = 16).Immobilisation group (40 digits): excellent 5% (n = 2); good 20% (n = 8); fair (satisfactory) 10% (n = 4); poor 65% (n = 26).Based on the above data, and adding the two cases with rupture as a poor outcome in the ultrasound group, there were fewer digits with a poor ROM outcome in the ultrasound group: 16/93 versus 26/40; RR 0.26, 95% CI 0.16 to 0.44; 133 digits; Analysis 9.2).Adverse eventsAdverse events included tendon ruptures and wound dehiscence which were reported as the number of participants with this adverse event in each group (Analysis 9.3). Data for extension lag deficits were not usable and hence the overall numbers of participants with adverse events were not calculated.Wound dehiscenceWound dehiscence was observed in four participants allocated to ultrasound. Ultrasound therapy was stopped and the four participants were excluded from the study. No control group participants experienced wound dehiscence.Tendon ruptureTwo participants allocated ultrasound experienced tendon rupture after three weeks.Extension lag deficits were also measured by the trial investigators. However, the available data were not usable for the following reasons. The method for calculating extension lag was not defined and was used interchangeably with flexion deformities in the publication. Extension lag was also expressed in a non‐standardised format as ranges of extension deficit (measured goniometrically) and these ranges differed between the groups. The time intervals for when this motion was achieved also differed between the groups; some data were reported at eight weeks and some at 12 weeks.Functional assessment using a patient reported outcome measureNot reported in either trial.Active range of motionTotal active motion was reported in Ozkan 2004 only. Ozkan 2004, which did not state how this outcome was derived, did not find evidence of a between‐group difference (MD ‐14.17 degrees, 95% CI ‐36.48 to 8.14; 41 digits; Analysis 10.1).Strickland's classification (number of digits (% of total digits)): One digit in each group was rated as a "poor" outcome based on the Strickland classification (Analysis 10.2). Data for all groups Strickland categories for the laser group were: excellent 60% (n = 12); good 25% (n = 5); fair 10% (n = 2); poor 5% (n = 1); and for the placebo group: excellent 58% (n = 11); good 16% (n = 3); fair 21% (n = 4); poor 5% (n = 1).Adverse eventsBetween the two trials, two adverse effects, both tendon rupture, were observed in Ozkan 2004 and one, a wound infection, in Poorpezeshk 2018 (Analysis 10.3).One participant of the laser group of Poorpezeshk 2018 experienced a wound infection, which was managed with conservative treatment.One tendon rupture was reported in each group of Ozkan 2004; both were excluded from the analysis for other outcome measures. No tendon rupture was reported in either group of Poorpezeshk 2018.Functional assessment using a patient‐reported outcome measureFunction was measured using two different questionnaires including the MHQ and a one‐item question on hand skills using a VAS. These were completed for each hand for each participant. Stenekes 2009 reported that there was no significant between group difference for either outcome.Active finger range of motionTAM was calculated per hand and recorded as a percentage of the other side. Stenekes 2009 reported that there was no significant difference between groups in TAM.Adverse eventsNot reported.