Clinical trial NCT05372497: Central Nervous System Focused Therapy in Frozen Shoulder
Official title: Effect of Central Nervous System Focused Therapy in Frozen Shoulder Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Frozen shoulder has been considered a self-limiting and benign disease with complete resolution of pain and ROM, but this can sometimes last for years. This prolonged pain and disability deprives patients of their routine life, occupational and recreational activities. Although appropriate treatment is needed so that they can quickly return to their lives, definitive treatment strategies have not been established and many different management strategies are used. The aim of this study is to investigate whether pain education and sensory education applied together with conventional physiotherapy are more effective than conventional physiotherapy alone.In this study, 21 people diagnosed with frozen shoulder who were referred by the doctor of Esenler Medipol Hospital, Department of Physical Therapy and Rehabilitation will be included in the study.

Outcome measures: Pain Beliefs Scale, Pain Catastrophizing Scale, PainDetect Questionnaire, Tampa Kinesiophobia Scale, Shoulder Pain and Disability Index, Visual Analog Scale, Electrogoniometer, Two-point discrimination test, Numeric Rating Sleep Scale and Right/ Left Judgement Task.

This study was designed as a prospective randomized controlled trial. 21 people were included in the study. Participants were randomly divided into two groups: Conventional physiotherapy group (CP group) (n=11), Conventional physiotherapy plus central nervous system focused treatment group (CP+CNS group) (n=10). Conventional physiotherapy was applied to both groups for 45-60 minutes, 5 days a week for 4 weeks.

The CP group treatment session will take place as follows: Scapular mobilization, passive stretches, stick exercises, pendulum exercises and shoulder flexion, extension, internal rotation, external rotation, horizontal abduction/ adduction strengthening exercises.

The CP+CNS group received central nervous system focused therapy that included chronic pain education, localization training, graphesthesia, graded motor imagery and mirror therapy in addition to conventional physiotherapy.

The IG group protocol includes:

1. week: Initial Evaluation, Conventional physiotherapy (CP), Chronic Pain Education, Localization Training Level 1, Right / Left Discrimination Training
2. week: CP, Motor Imagery, Localization Training Level 2
3. week: CP, Grafestesis Training, Isometric Exercise
4. week: CP, Mirror Therapy, Functional Exercises, Final Evaluation

Detailed description: First week:

* Initial Evaluation
* Conventional physiotherapy (CP) (5 days)
* Chronic Pain Education (5 days):Chronic pain education is a therapeutic treatment strategy that explains the patient's past experiences of pain in terms of neurobiological and neurophysiological rather than anatomical or biomechanical models. Detailed chronic pain education is needed to redefine the concept of pain and to convince the patient that the cause of their symptoms is hypersensitivity of the central nervous system rather than local tissue damage. For this reason, chronic pain education modules were created by the researcher to be presented to the participants in order to change their pain beliefs through the reconceptualization of pain. Nociceptive mechanisms in acute pain and chronic pain were explained comparatively at the beginning. A presentation supported by visuals and examples was prepared to guide during the chronic pain education, but a flexible schedule of 15-20 minutes was created by increasing the number of examples and in more detail according to the education level of the patient, preventing the patient from being bored during the session.
* Localization Therapy Level 1 (5 days): This level only the localization of the stimulus was trained. A grid-like sticky paper with 9 holes punched was placed over the affected shoulders of the participants and the training began by showing a standard photograph of the shoulder on which the 9-hole grid was marked. The spacing of the grids was determined on the basis of available data based on two-point separation of the shoulder joint.This data range was 43.18 mm ± 10.37 mm. The standard limits for placement of the 9-hole grid on the shoulder are as follows: 1 cm proximal to the acromioclavicular joint and the lower border of the insertion of the deltoid muscle. The thick end of the probe and the 9-hole grill and their placement on the shoulder are introduced. After the familiarization period, the patient continues training with the thick end of the probe (2 seconds) using a random number sequence. In the first week, stimulus was applied by asking random numbers 4 days a week, 3 sets every day and 20 numbers in each set.
* Right / Left Discrimination Training (5 days): In the first week, an online computer program, Recognise Shoulder (Recognise Online, NOI Group, Adelaide, SA, Australia) was used to present participants with randomly selected photographs of their right or left shoulder. Shoulder photos presented in various directions. Participants were asked to press one of the buttons on the left and right of the screen to indicate whether the photograph was of the right or left shoulder. An important point here was to give the response corresponding to the body part as quickly as possible, and for this purpose, the participants were asked to respond within 5 seconds during the application. The training was carried out in three sets, each set consisting of 30 photographs.

Second week:

* Conventional physiotherapy (CP)
* Motor Imagery (5 days): In our study, participants were asked to imagine they were moving their painful shoulders with motor imagery training. Participants were asked to sit in a comfortable position, close their eyes, and imagine being in an environment where they felt comfortable. Photographs containing 8 shoulder postures were used in the training. 8 photos were applied in two sets and 20 repetitions. Each photograph was shown live to the participants by the physiotherapist and the participant was asked to imagine the motion shown as painless, smooth and full range of motion. Participants were asked not to imagine watching themselves while imagining shoulder movements, but to perform the movements in the first person.
* Localization Training level 2 (5 days): They were asked to distinguish both the localization of the stimulus and the size of the probe used. The working pattern is the same as for localization level 1, but two types of probes are used, pointed (pencil tip) and coarse tip (mushroom). Three randomly applied sets of both position and probe sizes and a random array of 20 numbers in each set were used.

Third week:

* Conventional physiotherapy
* Grafestesis Training (5 days): In our study, randomized capital letters were drawn consecutively on the affected shoulder of the participant by the physiotherapist using the index finger. On the second day, the randomized letters were drawn in lowercase and the patient was asked to say the correct letter. On the third day, the randomized letters drawn on the shoulder were presented in different directions and the participant was asked to say the correct letter. On the fourth day, random letters were presented in slow, fast, and normal speed and the participant was asked to say the correct letter. On the fifth day, 20 meaningful words consisting of three letters were formed. It was written overlapping the participant's shoulder and the patient was asked to say the meaningful word.
* Isometric exercise (5 days): Three sets of isometric exercises including shoulder flexion, extension, abduction and adduction movements, each set consisting of 7-10 repetitions and each movement lasted for 10 seconds, were performed. The participant completed the movements with controlled breathing while performing the movements, and a 1-3 minute rest break was given between each set.

Fourth week:

* Conventional physiotherapy
* Mirror Therapy (5 day): A large mirror with wheels was placed in front of the participant with the unaffected arm facing the reflective side of the mirror, and the participant was allowed to flex the trunk to see the unaffected arm. Mirror therapy initially began with the unaffected arm watching its movements on the moon. It was said that when the participant was confident that he could do the mirror exercises painlessly, he could start performing the movements with the affected shoulder at the same time. Afterwards, progress was made towards active movements involving shoulder flexion, abduction, internal rotation and external rotation, including the affected arm. In the clinic, a training was planned for 2 sets, lasting 12-15 minutes, and rest periods of 1-3 minutes between each set.
* Functional Exercises (5 day): The movements that the participant had difficulty in daily life were determined during the individual interview, and exercises similar to these movements and specifically aimed at increasing functionality were planned in the clinic and applied for 15 minutes. Functional exercises wiping the wall opposite the wall at different degrees of flexion and abduction in close and far distances, wiping the wall with narrow and wide circumcision movements, picking up colored papers placed on the mirror at different angles and placing them at different angles, squeezing the ball while shoulder flexion and abduction involved rolling the ball wide and narrow with the shoulder at different angles.
* Final Evaluation

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with frozen shoulder with chronic pain lasting more than 3 months
* Being between the ages of 18-65
* Absence of fracture, dislocation or arthritis in the shoulder area evaluated by routine x-ray examination
* Patients who were not prescribed any medical treatment other than analgesics in the last 3 months were included.

Exclusion Criteria:

* Wide scar around the shoulder
* History of bilateral concurrent frozen shoulder
* If there has been surgical intervention on the affected shoulder
* Rotator cuff calcification
* Cervical radiculopathy
* History of physical therapy program for the same shoulder in the last 6 months

Primary outcomes:
measure: The Pain Catastrophizing Scale
timeFrame: Change from The Pain Catastrophizing Scale at 4 weeks
measure: Visual Analog Scale (VAS)
timeFrame: Change from Visual Analog Scale (VAS) at 4 weeks
measure: Electrogoniometer
timeFrame: Change from electrogoniometer at 4 weeks
measure: Two Point Discrimination Test
timeFrame: Change from two point discrimination test at 4 weeks
measure: Pain Beliefs Scale
timeFrame: Change from pain beliefs scale at 4 weeks
measure: Right/left Judgement Task
timeFrame: Change from right/left judgement task at 4 weeks
Secondary outcomes:
measure: Tampa Kinesiophobia Scale (TKS)
timeFrame: Change from tampa kinesiophobia scale (TKS) at 4 weeks
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from shoulder pain and disability index (SPADI) at 4 weeks
measure: Pain Detect (PD-Q)
timeFrame: Change from shoulder pain detect (PD-Q)at 4 weeks
measure: Graded Chronic Pain Scale-Revised
timeFrame: Change from graded chronic pain scale-revised at 4 weeks
measure: Sleep Scale
timeFrame: Change from sleep scale at 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Esenler Hospital
Study officials:
affiliation: Medipol University
name: Ayşe GÜRLÜK, MSc
role: PRINCIPAL_INVESTIGATOR
References: