Adhesive CapsulitisNCT06064396
Effects of Gong's Mobilization With and Without Stecco Fascial Therapy in Patients With Adhesive Capsulitis
A study testing Gong's Mobilization and Stecco Fascial Therapy in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Gong's Mobilization and Stecco Fascial Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Oct 2023to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Arif Memorial Teaching Hospital
Lahore, Punjab Province, 54600
About this study
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.
Read the 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.
- Conditions
- Adhesive Capsulitis
- Being tested
- Gong's Mobilization, Stecco Fascial Therapy
- Keywords
- Adhesive Capsulitis, Pain, Range of Motion
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gong's MobilizationOther
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gong's Mobilization with Stecco Fascial Therapy | Experimental | Participants in this group will receive Gong's Mobilization with Stecco Fascial Therapy Receives: Other: Gong's Mobilization; Other: Stecco Fascial Therapy |
| Gong's Mobilization | Active comparator | Participants in this group will receive Gong's Mobilization Receives: Other: Gong's Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4th week
Range of Motion Shoulder (Flexion)
Changes from baseline ROM range of motion of shoulder flexion will be taken with the help of universal goniometer.
Measured: 4th week
Range of Motion Shoulder (Abduction)
Changes from baseline ROM range of motion of shoulder abduction will be taken with the help of universal goniometer.
Measured: 4th week
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.
Measured: 4th week
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.
Measured: 4th week
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).
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start20 Oct 2023
- Primary completion30 Dec 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064396
- Sponsor's protocol ID
- REC/RCR&AHS/23/0136 Ifra Awan
- Status last verified
- Mar 2024
- First submitted
- 26 Sep 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20110457Tasto JP, Elias DW. Adhesive capsulitis. Sports Med Arthrosc Rev. 2007 Dec;15(4):216-21. doi: 10.1097/JSA.0b013e3181595c22.
PubMed 18004221Wang 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.
PubMed 23352186Tighe 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.
PubMed 18475240Wadsworth CT. Frozen shoulder. Phys Ther. 1986 Dec;66(12):1878-83. doi: 10.1093/ptj/66.12.1878.
PubMed 3786418Celik 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.
PubMed 21252605Day 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.
PubMed 19329049Russell 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.
PubMed 24630545
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gong's Mobilization With and Without Stecco Fascial Therapy in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06064396
- Acronym / sponsor ID
- REC/RCR&AHS/23/0136 Ifra Awan
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, Pain, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gong's Mobilization with Stecco Fascial Therapy | Experimental | Other: Gong's Mobilization, Other: Stecco Fascial TherapyParticipants in this group will receive Gong's Mobilization with Stecco Fascial Therapy |
| Gong's Mobilization | Active comparator | Other: Gong's MobilizationParticipants in this group will receive Gong's Mobilization |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gong's MobilizationThe 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. | Other | Gong's Mobilization, Gong's Mobilization with Stecco Fascial Therapy |
| Stecco Fascial TherapyThe 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. | Other | Gong's Mobilization with Stecco Fascial Therapy |
Primary outcome
Pain: Numeric Pain Rating Scale (NPRS)
Time frame: 4th week
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)
Time frame: 4th week
Changes from baseline ROM range of motion of shoulder flexion will be taken with the help of universal goniometer.
Range of Motion Shoulder (Abduction)
Time frame: 4th week
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)
Time frame: 4th week
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)
Time frame: 4th week
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
Time frame: 4th week
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 20110457Neviaser 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.
- Background: PubMed 18004221Tasto JP, Elias DW. Adhesive capsulitis. Sports Med Arthrosc Rev. 2007 Dec;15(4):216-21. doi: 10.1097/JSA.0b013e3181595c22.
- Background: PubMed 23352186Wang 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.
- Background: PubMed 18475240Tighe 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.
- Background: PubMed 3786418Wadsworth CT. Frozen shoulder. Phys Ther. 1986 Dec;66(12):1878-83. doi: 10.1093/ptj/66.12.1878.
- Background: PubMed 21252605Celik 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.
- Background: PubMed 19329049Day 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.
- Background: PubMed 24630545Russell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabiya Noor, Phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gong's Mobilization and Stecco Fascial Therapy in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: Numeric Pain Rating Scale (NPRS) (time frame: 4th week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064396, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.