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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05915689
Other study ID # REC/RCR &AHS/23/0125
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2023
Est. completion date October 2, 2023

Study information

Verified date November 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date October 2, 2023
Est. primary completion date September 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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

Locations

Country Name City State
Pakistan Hafeez clinic Sialkot Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale (NPRS) 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
Primary SPADI(shoulder pain and disability index) 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 Universal Goniometer 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
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