Adhesive CapsulitisNCT05915689
Comparative Effects of Myofascial Arm Pull and Post Isometric Relaxation Techniques in Adhesive Capsulitis
A study testing Myofascial arm pull technique and post isometric relaxation technique in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Myofascial arm pull technique and post isometric relaxation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Mar 2023to 2 Oct 2023
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adhesive Capsulitis
- Being tested
- Myofascial arm pull technique, post isometric relaxation technique
- Keywords
- Adhesive Capsulitis, Pain, Shoulder, Joint 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.
Myofascial arm pull techniqueOther
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 techniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| Myofascial arm pull technique | Experimental | subjects in this group will be treated with myofascial arm pull technique Receives: Other: Myofascial arm pull technique |
| Post Isomeric relaxation technique | Experimental | subjects in this group will be treated with post isometric relaxation technique Receives: Other: post isometric relaxation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks
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)
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start3 Mar 2023
- Primary completion28 Sep 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sana Hafeez, PhD*, Principal investigator, Riphah International University Lahore Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915689
- Sponsor's protocol ID
- REC/RCR &AHS/23/0125
- Status last verified
- Nov 2023
- First submitted
- 14 Jun 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33010843Cho 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.
PubMed 31475043Tedla 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.
PubMed 31789299Razzaq 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.
PubMed 35099430Duzgun 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.
PubMed 31475938Cohen 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.
PubMed 32904783
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Myofascial Arm Pull and Post Isometric Relaxation Techniques on Pain, Range of Motion and Functional Disability in Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05915689
- Acronym / sponsor ID
- REC/RCR &AHS/23/0125
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive Capsulitis, Pain, Shoulder, Joint Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 23 Jun 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial arm pull technique | Experimental | Other: Myofascial arm pull techniquesubjects in this group will be treated with myofascial arm pull technique |
| Post Isomeric relaxation technique | Experimental | Other: post isometric relaxation techniquesubjects in this group will be treated with post isometric relaxation technique |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Myofascial arm pull techniquepatient 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. | Other | Myofascial arm pull technique |
| post isometric relaxation techniqueThe 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 | Other | Post Isomeric relaxation technique |
Primary outcome
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)
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)
1 secondary outcome
Universal Goniometer
Time frame: 6 weeks
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 13 Nov 2023.
- Background: PubMed 33010843Rangan 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.
- Background: PubMed 31475043Cho 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.
- Background: PubMed 31789299Tedla 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.
- Background: PubMed 35099430Razzaq 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.
- Background: PubMed 31475938Duzgun 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.
- Background: PubMed 32904783Cohen 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.
- 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.
Sana Hafeez, PhD* principal investigator
Riphah International University Lahore Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial arm pull technique and post isometric relaxation technique 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 5 inclusion and 6 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 13 Nov 2023. 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?
Numeric Pain Rating Scale (NPRS) (time frame: 6 weeks). The study lists 2 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 NCT05915689, which also lists 6 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 13 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.