Clinical trial NCT02976974: Efficacy of Manual Therapy and Exercise in Patients With Shoulder Adhesive Capsulitis. A Randomized Clinical Trial.
Official title: Efficacy of Manual Therapy and Therapeutic Exercise in Patients With Shoulder Adhesive Capsulitis. Which Factors Are More Correlated With?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Keywords: chronic pain
central sensitization
function
force
ultrasonography
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive capsulitis of the shoulder will be studied. Furthermore, different biomechanic and psychosocial factors will be measured with a nine month follow-up

Detailed description: Adhesive capsulitis of the shoulder is a painful entity characterized by stiffness in the shoulder joint. There exist different clinical trial related to this pathology, however a lack of information of both efficacy and methodology used in manual therapy treatment remains unclear, as well as therapeutic exercise treatment. Furthermore, the duration of the improvement after different conservative treatments is also unknown. Besides, little is known about which factors are more correlated with pain and function.Thus, biomechanic and psychosocial factors together with ultrasound measurements and blood glucose concentration (see "outcome and secondary measures" section ) will be analyzed before and after the treatment, with a nine months follow up. Results will be spread showing short term effects and long term effects in different publications.

Hence, the aim of this study is twofold: i)To analyze the efficacy of manual therapy and therapeutic exercise in patients with shoulder adhesive capsulitis; ii) To correlate pain and function with ultrasonography, biomechanic and psychosocial factors, as well as blood glucose concentration, before and after the treatments proposed with a nine months follow up.

Method

This study is designed as a clinical trial, with two randomised parallel groups comparing two different conservative intervention (MT vs MT+E) (See "Arms and Interventions" section). It will be carried out in different Hospital and primary care centers where patients suffering from adhesive capsulitis of the shoulder will be asked to participate in the project. If participants are eligible then they will be include in the study. All participants will have to sign informed consent after be shown about the whole project as by written (informative sheet) as by speech from the physiotherapist in charge.

Once include in the study definitely, all factors detailed (see "outcome measures" section) will be measured. Also, every factor will be correlated with shoulder pain and function. This way, the investigators could predict which factor are more correlated with. Furthermore, if significant correlations are found, such factors could be used as predictors or monitoring tool when patients with shoulder adhesive capsulitis are treated

Eligibility criteria: Inclusion Criteria:

* People suffering from adhesive capsulitis as indicated by passive range of motion loss \>25% in at least 2 movement planes, together with at least 50% loss of passive external rotation in comparison with the uninvolved shoulder.

Exclusion Criteria:

* Shoulder pain that was deemed to be originating from any passive and/or neck movement or if there was a neurological impairment, osteoporosis, haemophilia and/or malignancies
* Corticoid injections during the six months prior to the study
* Analgesic-antiinflammatory medication intake during the intervention phase of the study.

Primary outcomes:
measure: Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Secondary outcomes:
measure: Change from baseline pressure algometry at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline ultrasonography at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline electromyography at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline dynamometry at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline blood glucose concentration at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline range of movement (ROM) at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline heart rate variability (HRV) at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline CSI questionnaire at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline "pain vigilance and awareness" questionnaire at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline pain Catastrophizing Scale questionnaire at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline short form-36 (SF-36) at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline McGill questionnaire at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
measure: Change from baseline Autonomic Symptom Profile questionnaire (ASP) at nine months
timeFrame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Other outcomes:
Locations:
city: Fuengirola
country: Spain
facility: Las Albarizas primary care centre
state: Malaga
city: Fuengirola
country: Spain
facility: Las Lagunas Care Centre
state: Malaga
city: Marbella
country: Spain
facility: San Pedro primary care centre
state: Malaga
Study officials:
affiliation: UNIVERSITY OF MALAGA, SPAIN
name: ALEJANDRO LUQUE-SUAREZ, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: