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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06064396
Other study ID # REC/RCR&AHS/23/0136 Ifra Awan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2023
Est. completion date January 25, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effects of Gong's mobilization with and without Stecco Fascial therapy on pain, range of motion and function in patients with Adhesive capsulitis.


Description:

Adhesive capsulitis is characterized by a painful, progressive loss of both active and passive glenohumeral mobility that results from the glenohumeral joint capsule's increasing fibrosis and eventual rigidity. The clinical syndrome known as "frozen shoulder" restricts active and passive range of motion (ROM) in flexion, abduction, and rotation, among other movements. A research conducted on effectiveness of Gong's mobilisation versus muscle energy technique on pain and functional ability of shoulder in phase II adhesive capsulitis. He included 50 subjects and then randomly allocated them into two groups. Duration of treatment was 6 sessions per week for two weeks. The Gong's mobilisation (Group A) pull was maintained for about 10-15 seconds. Maitland's grade 3 and 4 was performed to increase the range. Muscle energy technique was applied for 5 repetitions per set, 5 days a week for 2 weeks. Group A showed significant improvement than Group B. This implies that Gong's mobilisation is more beneficial in improving ROM, reducing pain, improving functional ability. A study conducted to determine the effect of Fascial Manipulation on the Internal Rotation Range of Motion in athletes with GIRD. Asymptomatic overhead athletes with GIRD more than 20° when compared with the non-dominant shoulder were randomly assigned to two groups. The experimental group has received three sessions of FM treatment in two weeks. FM applied to densified Centre of Coordination (CC) points located on the myofascial sequences for 5 to 8 minutes at each CC point. The control group has received three sessions of posterior shoulder capsule release using a tennis ball under supervision.This study indicates that FM may be used as an adjunct to stretching in asymptomatic participants with GIRD to increase the IRROM. There is limited literature available regarding the combined effects of Gong's Mobilization with Stecco Fascial manipulative therapy on pain, range of motion and function in patients with adhesive capsulitis. Previous literature was carried on smaller sample size and for two weeks without any follow up. In previous studies long term effects were not known and only shoulder abduction and internal rotation range of motion were measured. Therefore, in this study combined effects of Gong's mobilization and Stecco Fascial Therapy will be study on pain, range of motion and function in patients with Adhesive Capsulitis. This study will include all range of motion of shoulder joint and also include home plan after the session.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date January 25, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria: - Both male and female patients - Patients with positive capsular pattern of glenohumeral joint which is external rotation, abduction and internal rotation - Patients aged 35-60 years with shoulder pain and reduction in range of motion - Unilateral stage II frozen shoulder with shoulder pain and stiffness for more than 3 months Exclusion Criteria: - Patients with additional cervical or shoulder pathology - Patients with shoulder dislocation, rotator cuff rupture and injury - Medical red flag history (tumor, metabolic diseases, rheumatoid arthritis, osteoporosis or Infection) - Neurological disorder or symptomatic herniated disc or severe disorders of the cervical spine - History of Severe trauma or any fracture or surgery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gong's Mobilization
The duration of intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with Gong's Mobilization.
Stecco Fascial Therapy
The duration of intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with stecco fascial therapy.

Locations

Country Name City State
Pakistan Arif Memorial Teaching Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Celik D. Comparison of the outcomes of two different exercise programs on frozen shoulder. Acta Orthop Traumatol Turc. 2010;44(4):285-92. doi: 10.3944/AOTT.2010.2367. — View Citation

Day JA, Stecco C, Stecco A. Application of Fascial Manipulation technique in chronic shoulder pain--anatomical basis and clinical implications. J Bodyw Mov Ther. 2009 Apr;13(2):128-35. doi: 10.1016/j.jbmt.2008.04.044. Epub 2008 Jun 24. — View Citation

Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28. — View Citation

Russell S, Jariwala A, Conlon R, Selfe J, Richards J, Walton M. A blinded, randomized, controlled trial assessing conservative management strategies for frozen shoulder. J Shoulder Elbow Surg. 2014 Apr;23(4):500-7. doi: 10.1016/j.jse.2013.12.026. — View Citation

Tasto JP, Elias DW. Adhesive capsulitis. Sports Med Arthrosc Rev. 2007 Dec;15(4):216-21. doi: 10.1097/JSA.0b013e3181595c22. — View Citation

Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39. — View Citation

Wadsworth CT. Frozen shoulder. Phys Ther. 1986 Dec;66(12):1878-83. doi: 10.1093/ptj/66.12.1878. — View Citation

Wang K, Ho V, Hunter-Smith DJ, Beh PS, Smith KM, Weber AB. Risk factors in idiopathic adhesive capsulitis: a case control study. J Shoulder Elbow Surg. 2013 Jul;22(7):e24-9. doi: 10.1016/j.jse.2012.10.049. Epub 2013 Jan 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain: Numeric Pain Rating Scale (NPRS) Changes from baseline Numeric pain rating scale is The 11-point scale used to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. Numeric pain scales have been shown to be reliable and valid with validity range from 0.86 to 0.95 and high test-retest reliability r=0.96 4th week
Primary Range of Motion Shoulder (Flexion) Changes from baseline ROM range of motion of shoulder flexion will be taken with the help of universal goniometer. 4th week
Primary Range of Motion Shoulder (Abduction) Changes from baseline ROM range of motion of shoulder abduction will be taken with the help of universal goniometer. 4th week
Primary Range of Motion Shoulder (External rotation) Changes from baseline ROM range of motion of shoulder external rotation will be taken with the help of universal goniometer. 4th week
Primary Range of Motion Shoulder (Internal rotation) Changes from baseline ROM range of motion of shoulder internal rotation will be taken with the help of universal goniometer. 4th week
Primary Function: Shoulder Pain and Disability Index (SPADI) Questionnaire Changes from baseline SPADI. SPADI questionnaire is used for the self-assessment of symptoms and function of the shoulder. 13 items (total score): 5 items for pain and 8 for function (sub scores). Response options/scale. All SPADI items are originally scored on a visual analog scale (VAS) from no pain/no difficulty to worst pain imaginable/so difficult required help. The VAS line was divided into 12 equal intervals to obtain a 12-point numerical rating scale (NRS) ranging from 0 (best) to 11 (worst). 4th week
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