- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05915689
Comparative Effects of Myofascial Arm Pull and Post Isometric Relaxation Techniques in Adhesive Capsulitis
November 10, 2023 updated by: Riphah International University
Comparative Effects of Myofascial Arm Pull and Post Isometric Relaxation Techniques on Pain, Range of Motion and Functional Disability in Adhesive Capsulitis
Adhesive capsulitis is defined as a condition characterized by pain and stiffness in shoulder which results in both active and passive movement loss.
The purpose of this study is to investigate the effects of shoulder directed treatment approach using Myofascial arm pull technique on the pain, range of motion and quality of life in patients with adhesive capsulitis and compare its effectiveness with Post Isometric Relaxation technique.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Frozen shoulder is a common debilitating disorder characterized by shoulder pain and progressive loss of shoulder movement.
Frozen shoulder is frequently associated with other systemic conditions or occurs following periods of immobilization, and has a protracted clinical course, which can be frustrating for patients as well as health-care professionals .Loyd define secondary frozen shoulder as a condition resulting from painful spasm on shoulder which causes activity limitation and dependency on opposite arm.
In general population, the prevalence rate of frozen shoulder is around 2% to 5% and it ranges from 11% to 30% in diabetic population.
Women are affected more than male and approx.
70% cases of frozen shoulder are on female.
Among all frozen shoulder cases; around 20% to 30% patients develop frozen shoulder on opposite shoulder.
Most of the frozen shoulder cases develop on non dominant shoulder.
Adhesive Capsulitis of Shoulder is seen commonly at age of 40-65 years.
Traditionally, FS has been regarded as a self-limiting and benign disease with complete recovery of pain and ROM.
However, this condition can sometimes last for years.
In one study, 50% of patients were still experiencing pain or stiffness of the shoulder at a mean of 7 years from the onset of the condition, although only 11% reported functional limitation.
Different Physical therapy interventions used in patients with frozen shoulder frequently include modalities, manual techniques, and therapeutic exercise.
Exercises given in the treatment of adhesive capsulitis consists of active ROM, Codman's exercise, wall walks, shoulder wheel, pulley, active and passive stretching, and rotator cuff and scapular strengthening exercises, METs, Gong mobilization, Mulligan mobilization.
Many strategies have been employed in clinical practice to improve range and strength in prior research.
There are limited studies regarding comparisons between the effects of myofascial arm pull and post isometric relaxation techniques that give the evidence of improving end painful ranges of adhesive capsulitis for long term effect.
This study will be conducted to check the positive effect of myofascial arm pull technique and post isometric relaxation to increase end range in adhesive capsulitis.
The literature review was conducted using different databases and the eleven selected articles fulfilled the criteria and included in research.
Conclusion: Addition of Myofascial release technique and post isometric relaxation technique both as an adjunct to conventional treatment will have better benefits and faster recovery in patients with frozen shoulder but there are limited studies about the comparison of myofascial arm pull and post isometric relaxation techniques on pain, range of motion and quality of life in adhesive capsulitis.
I will conduct this study to determine which technique is better to gain painful end ranges in adhesive capsulitis.
So that this study will provide different treatment strategies for frozen shoulder to improve end painful ranges.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Sialkot, Punjab, Pakistan, 51310
- Hafeez clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Unilateral frozen shoulder
- male and female
- Age between 40 and 60
- grade 2 frozen shoulder with pain lasting more than three month;
- capsular pattern of shoulder( External rotation, Abduction, Internal rotation)
Exclusion Criteria:
- Acute inflammation
- Subjects with systemic disease
- Dislocation and fracture in and around the shoulder,
- Rheumatoid arthritis
- History of Subjects with diabetes mellitus, osteoporosis or malignancies in shoulder region
- Past surgery around shoulder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Myofascial arm pull technique
subjects in this group will be treated with myofascial arm pull technique
|
patient in supine position move the arm passively in abduction to the restricted barrier and pull the arm only enough traction was used to counterbalance the weight of the patient's arm.
Stretch was hold until the fibers were released, and then, stretch was given again by increasing traction.
This sequence was repeated until an end feel was reached.
same procedure for flexion and scapular protraction and Horizontal-adduction. Repetition will be 4-5 reps.
per set, 3 times per week for 18 sessions.
|
|
Experimental: Post Isomeric relaxation technique
subjects in this group will be treated with post isometric relaxation technique
|
The therapist stood in front of the patient, then placed one hand over the top of the subject's involved shoulder.
The therapist cups the gleno humeral joint to palpate for motion and the subjects are directed to press the elbow towards therapist hand for shoulder abduction, internal rotation and external rotation.
Muscle energy technique was applied for five repetitions per set, five sets per session, one session per day, three days a week for six weeks with each repetition maintained for the duration of 7-10 second
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 6 weeks
|
An NPRS is described as an 11-point scale with scores from 0 to 10 and anchors of 0 = no pain and 10 = worst possible pain Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in cervical spine.
The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
|
6 weeks
|
|
SPADI(shoulder pain and disability index)
Time Frame: 6 weeks
|
The questionnaire consists of 13 items grouped into pain and disability subscales, the questions starting with "How severe is your pain." and "How much difficulty do you have.",
respectively.
Items mainly deal with various activities of daily living (ADL) that may or may not be problematic to the patient.
Items are rated on visual analogue scales to produce a score for each subscale, and the means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst)
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Universal Goniometer
Time Frame: 6 weeks
|
The universal mechanical goniometer (Plastic Goniometer-360 Degree Head - 12 inch arms) is a high-resolution plastic goniometer that permits observation of the axis of motion and ROM of the joint being measured The goniometer generally consists of a stationary arm, movable arm and a fulcrum.
The circular or semi-circular portion is the centerpiece, which is the body of goniometer with a protractor printed on its face and the fulcrum of movable arm at its center.
Generally, the fulcrum of the goniometer is placed over the center of a joint during measurement.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sana hafeez, phD*, Riphah International University Lahore Campus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.
- Tedla JS, Sangadala DR. Proprioceptive neuromuscular facilitation techniques in adhesive capsulitis: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):482-491.
- Rangan A, Brealey SD, Keding A, Corbacho B, Northgraves M, Kottam L, Goodchild L, Srikesavan C, Rex S, Charalambous CP, Hanchard N, Armstrong A, Brooksbank A, Carr A, Cooper C, Dias JJ, Donnelly I, Hewitt C, Lamb SE, McDaid C, Richardson G, Rodgers S, Sharp E, Spencer S, Torgerson D, Toye F; UK FROST Study Group. Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial. Lancet. 2020 Oct 3;396(10256):977-989. doi: 10.1016/S0140-6736(20)31965-6. Erratum In: Lancet. 2021 Jan 9;397(10269):98.
- Razzaq A, Nadeem RD, Akhtar M, Ghazanfar M, Aslam N, Nawaz S. Comparing the effects of muscle energy technique and mulligan mobilization with movements on pain, range of motion, and disability in adhesive capsulitis. J Pak Med Assoc. 2022 Jan;72(1):13-16. doi: 10.47391/JPMA.1360.
- Duzgun I, Turgut E, Eraslan L, Elbasan B, Oskay D, Atay OA. Which method for frozen shoulder mobilization: manual posterior capsule stretching or scapular mobilization? J Musculoskelet Neuronal Interact. 2019 Sep 1;19(3):311-316.
- Cohen C, Tortato S, Silva OBS, Leal MF, Ejnisman B, Faloppa F. Association between Frozen Shoulder and Thyroid Diseases: Strengthening the Evidences. Rev Bras Ortop (Sao Paulo). 2020 Aug;55(4):483-489. doi: 10.1055/s-0039-3402476. Epub 2020 Apr 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2023
Primary Completion (Actual)
September 28, 2023
Study Completion (Actual)
October 2, 2023
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
June 14, 2023
First Posted (Actual)
June 23, 2023
Study Record Updates
Last Update Posted (Estimated)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 10, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR &AHS/23/0125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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