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Effects of Gong's Mobilization With and Without Stecco Fascial Therapy in Patients With Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Gong's Mobilization with Stecco Fascial Therapy
Gong's Mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive Capsulitis, Pain, Range of Motion

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arif Memorial Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gong's Mobilization with Stecco Fascial Therapy

Gong's Mobilization

Arm Description

Participants in this group will receive Gong's Mobilization with Stecco Fascial Therapy

Participants in this group will receive Gong's Mobilization

Outcomes

Primary Outcome Measures

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
Range of Motion Shoulder (Flexion)
Changes from baseline ROM range of motion of shoulder flexion will be taken with the help of universal goniometer.
Range of Motion Shoulder (Extension)
Changes from baseline ROM range of motion of shoulder extension will be taken with the help of universal goniometer.
Range of Motion Shoulder (Abduction)
Changes from baseline ROM range of motion of shoulder abduction will be taken with the help of universal goniometer.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
September 26, 2023
Last Updated
September 26, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06064396
Brief Title
Effects of Gong's Mobilization With and Without Stecco Fascial Therapy in Patients With Adhesive Capsulitis
Official Title
Effects of Gong's Mobilization With and Without Stecco Fascial Therapy in Patients With Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
December 8, 2023 (Anticipated)
Study Completion Date
January 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive Capsulitis, Pain, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
Masking
Participant
Masking Description
Blinding,refers to a practice where study participants are prevented from knowing certain information that may somehow influence them-thereby tainting the results.
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gong's Mobilization with Stecco Fascial Therapy
Arm Type
Experimental
Arm Description
Participants in this group will receive Gong's Mobilization with Stecco Fascial Therapy
Arm Title
Gong's Mobilization
Arm Type
Active Comparator
Arm Description
Participants in this group will receive Gong's Mobilization
Intervention Type
Other
Intervention Name(s)
Gong's Mobilization with Stecco Fascial Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gong's Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain: Numeric Pain Rating Scale (NPRS)
Description
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
Time Frame
4th week
Title
Range of Motion Shoulder (Flexion)
Description
Changes from baseline ROM range of motion of shoulder flexion will be taken with the help of universal goniometer.
Time Frame
4th week
Title
Range of Motion Shoulder (Extension)
Description
Changes from baseline ROM range of motion of shoulder extension will be taken with the help of universal goniometer.
Time Frame
4th week
Title
Range of Motion Shoulder (Abduction)
Description
Changes from baseline ROM range of motion of shoulder abduction will be taken with the help of universal goniometer.
Time Frame
4th week
Title
Range of Motion Shoulder (External rotation)
Description
Changes from baseline ROM range of motion of shoulder external rotation will be taken with the help of universal goniometer.
Time Frame
4th week
Title
Range of Motion Shoulder (Internal rotation)
Description
Changes from baseline ROM range of motion of shoulder internal rotation will be taken with the help of universal goniometer.
Time Frame
4th week
Title
Function: Shoulder Pain and Disability Index (SPADI) Questionnaire
Description
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).
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, Phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arif Memorial Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, Phd
Phone
03344355660
Email
rabiya.noor@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Ifra Zulqarnain Awan, MS OMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20110457
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.
Results Reference
background
PubMed Identifier
18004221
Citation
Tasto JP, Elias DW. Adhesive capsulitis. Sports Med Arthrosc Rev. 2007 Dec;15(4):216-21. doi: 10.1097/JSA.0b013e3181595c22.
Results Reference
background
PubMed Identifier
23352186
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.
Results Reference
background
PubMed Identifier
18475240
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.
Results Reference
background
PubMed Identifier
3786418
Citation
Wadsworth CT. Frozen shoulder. Phys Ther. 1986 Dec;66(12):1878-83. doi: 10.1093/ptj/66.12.1878.
Results Reference
background
PubMed Identifier
21252605
Citation
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.
Results Reference
background
PubMed Identifier
19329049
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.
Results Reference
background
PubMed Identifier
24630545
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.
Results Reference
background

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Effects of Gong's Mobilization With and Without Stecco Fascial Therapy in Patients With Adhesive Capsulitis

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