Adhesive CapsulitisNCT04993092
Mulligan Mobilization Technique and Muscle Energy Technique on Pain and ROM
A study testing muscle energy technique and mulligan mobilization technique in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
this study will be a randomized clinical trial. This study will be conducted in Nishat Latif Hospital, Barath, Sialkot. A sample size of 22 patients will be taken. Patients will be divided into two groups by lottery method. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- muscle energy technique and mulligan mobilization technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2021to 10 Aug 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pain in shoulder for at least 3 months
- Unilateral frozen shoulder of stage 3 and 4
- Capsular pattern i.e. (lateral rotation, Abduction, Medial rotation)
Who cannot join
- Secondary capsulitis
- Shoulder injury such as proximal humerus fracture.
- History of Neurological deficit i.e. cervical stenosis, myelopathy.
- Prolong immobilization due to cardiothoracic surgery, neurosurgery.
- Shoulder surgical history such as shoulder arthroplasty.
- History of other pathological condition of shoulders i.e. Impingement syndrome, rotator cuff tear or any shoulder injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Effects of Mulligan Mobilization Technique and Muscle Energy Technique on Pain and Range of Motion in Adhesive Capsulitis
this study will be a randomized clinical trial. This study will be conducted in Nishat Latif Hospital, Barath, Sialkot. A sample size of 22 patients will be taken. Patients will be divided into two groups by lottery method. Group A will be treated with mulligan mobilization technique and conventional physiotherapy with Transcutaneous electrical nerve stimulation and electrical heating pad. Group B will be treated with muscle energy technique and conventional treatment of Transcutaneous electrical nerve stimulation and electrical hot pack. Both groups will receive treatment for5 weeks,2 sessions in a week with baseline and 6 weeks treatment reading will be taken. The outcome measures Numeric pain rating scale, disabilities of the arm, shoulder and hand, Shoulder Pain and Disability Index . data will be analyzed by Statistical Package for the Social Sciences 25.
Read the detailed description
Frozen shoulder, also known as adhesive capsulitis, is a condition characterized by stiffness and pain in your shoulder joint. A condition in which a person has severe limitation of the range of motion of the shoulder due to scarring around the shoulder joint. Adhesive capsulitis is an unwanted consequence of rotator cuff disease that involves damage to the rotator cuff. Muscle energy technique involves careful positioning of an area of the body by the physical therapist. After positioning, you will be asked to contract the muscle or resist a movement done by the physical therapist. This will be followed by a stretch to lengthen the same or opposite muscle group.
This will be followed by a stretch to lengthen the same or opposite muscle group. Mulligan's technique "combines the sustained application of manual gliding force to a joint, with the aim of repositioning bone positional faults while enabling concurrent physiological (osteo-kinematic) motion of the joint. Essentially, this means repositioning a joint to enable proper motion while taking that joint through pain-free passive and active range of motion (ROM).
Mulligan Manual Therapy can be used to help treat a variety of injuries and pain including neck pain, back pain and upper and lower extremity injuries. Designed to reduce pain and improve the patient's range of motion the Mulligan technique involves Natural Apophyseal Glides (NAGS), Sustained Natural Apophyseal Glides (SNAGS) and Mobilization with Movement (MWM) for the treatment of musculoskeletal injuries.
The American Academy of Orthopedic Surgeons describe three stages: Freezing, or painful stage: Pain increases gradually, making shoulder motion harder and harder. Pain tends to be worse at night. Frozen: Pain does not worsen, and it may decrease at this stage. The shoulder remains stiff. Thawing: Movement gets easier and may eventually return to normal. Signs and symptoms typically begin gradually, worsen over time and then resolve, usually within one to three years.
- Conditions
- Adhesive Capsulitis
- Being tested
- muscle energy technique, mulligan mobilization technique
- Keywords
- Frozen shoulder
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle energy techniqueOther
Post facilitation stretch Patient perform isometrics for 15 seconds then therapist rapidly move the shoulder to the end range
mulligan mobilization techniqueOther
Sustain Posterolateral glide with belt and then told Patient to move in following pattern (internal rotation, external rotation, abduction, wall sliding)
| Study group | Role | What they receive |
|---|---|---|
| mulligan mobilization technique | Experimental | Sustain Posterolateral glide with belt and then told Patient to move in following pattern (internal rotation, external rotation, abduction, wall sliding) Receives: Other: mulligan mobilization technique |
| muscle energy technique | Active comparator | Post facilitation stretch Patient perform isometrics for 15 seconds then therapist rapidly move the shoulder to the end range Receives: Other: muscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quick Disabilities of the Arm, Shoulder and Hand
The Quick Disabilities of the Arm, Shoulder and Hand only contains subset of 11 items. it is a self-reported questionnaire in which the response options are presented as 5-point Likert scales.
At least 10 of the 11 items must be completed for a score to be calculated The scores range from 0 (no disability) to 100 (most severe disability).
Measured: 4th week
The Shoulder Pain and Disability Index
it is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily living requiring the use of the upper extremities. The pain subscale is a composite measure and has 5-items and the Disability subscale is a composite measure and has 8-items.
Total pain score (which is composite measure): / 50 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 40)
Total disability score (which is composite measure): / 80 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 70)
Total Shoulder Pain and Disability score: / 130 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 120)
The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Measured: 4th week
Goniometry
To measure Range of Motion at Shoulder joint.
Measured: 4th week
Secondary outcomes (1)
Numeric pain rating scale
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
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 posted6 Aug 2021
- Study start10 Jan 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993092
- Sponsor's protocol ID
- REC/Lhr/20/0115 Sumaira
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodridge JP. Muscle energy technique: definition, explanation, methods of procedure. J Am Osteopath Assoc. 1981 Dec;81(4):249-54. No abstract available.
PubMed 7319853Campbell SM, Winkelmann RR, Walkowski S. Osteopathic manipulative treatment: novel application to dermatological disease. J Clin Aesthet Dermatol. 2012 Oct;5(10):24-32.
PubMed 23125887Jain TK, Sharma NK. The effectiveness of physiotherapeutic interventions in treatment of frozen shoulder/adhesive capsulitis: a systematic review. J Back Musculoskelet Rehabil. 2014;27(3):247-73. doi: 10.3233/BMR-130443.
PubMed 24284277Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
PubMed 26304789Jones S, Hanchard N, Hamilton S, Rangan A. A qualitative study of patients' perceptions and priorities when living with primary frozen shoulder. BMJ Open. 2013 Sep 26;3(9):e003452. doi: 10.1136/bmjopen-2013-003452.
PubMed 24078753Solomonow M, Krogsgaard M. Sensorimotor control of knee stability. A review. Scand J Med Sci Sports. 2001 Apr;11(2):64-80. doi: 10.1034/j.1600-0838.2001.011002064.x.
PubMed 11252464Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
PubMed 32202646Doner G, Guven Z, Atalay A, Celiker R. Evalution of Mulligan's technique for adhesive capsulitis of the shoulder. J Rehabil Med. 2013 Jan;45(1):87-91. doi: 10.2340/16501977-1064.
PubMed 23037929Nicholson GG. The effects of passive joint mobilization on pain and hypomobility associated with adhesive capsulitis of the shoulder. J Orthop Sports Phys Ther. 1985;6(4):238-46. doi: 10.2519/jospt.1985.6.4.238.
PubMed 18802309
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Effects of Mulligan Mobilization Technique and Muscle Energy Technique on Pain and Range of Motion in Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT04993092
- Acronym / sponsor ID
- REC/Lhr/20/0115 Sumaira
- Conditions
- Adhesive Capsulitis
- Keywords
- Frozen shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 6 Aug 2021 (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.
this study will be a randomized clinical trial. This study will be conducted in Nishat Latif Hospital, Barath, Sialkot. A sample size of 22 patients will be taken. Patients will be divided into two groups by lottery method. Group A will be treated with mulligan mobilization technique and conventional physiotherapy with Transcutaneous electrical nerve stimulation and electrical heating pad. Group B will be treated with muscle energy technique and conventional treatment of Transcutaneous electrical nerve stimulation and electrical hot pack. Both groups will receive treatment for5 weeks,2 sessions in a week with baseline and 6 weeks treatment reading will be taken. The outcome measures Numeric pain rating scale, disabilities of the arm, shoulder and hand, Shoulder Pain and Disability Index . data will be analyzed by Statistical Package for the Social Sciences 25.
Detailed description
Frozen shoulder, also known as adhesive capsulitis, is a condition characterized by stiffness and pain in your shoulder joint. A condition in which a person has severe limitation of the range of motion of the shoulder due to scarring around the shoulder joint. Adhesive capsulitis is an unwanted consequence of rotator cuff disease that involves damage to the rotator cuff. Muscle energy technique involves careful positioning of an area of the body by the physical therapist. After positioning, you will be asked to contract the muscle or resist a movement done by the physical therapist. This will be followed by a stretch to lengthen the same or opposite muscle group.
This will be followed by a stretch to lengthen the same or opposite muscle group. Mulligan's technique "combines the sustained application of manual gliding force to a joint, with the aim of repositioning bone positional faults while enabling concurrent physiological (osteo-kinematic) motion of the joint. Essentially, this means repositioning a joint to enable proper motion while taking that joint through pain-free passive and active range of motion (ROM).
Mulligan Manual Therapy can be used to help treat a variety of injuries and pain including neck pain, back pain and upper and lower extremity injuries. Designed to reduce pain and improve the patient's range of motion the Mulligan technique involves Natural Apophyseal Glides (NAGS), Sustained Natural Apophyseal Glides (SNAGS) and Mobilization with Movement (MWM) for the treatment of musculoskeletal injuries.
The American Academy of Orthopedic Surgeons describe three stages: Freezing, or painful stage: Pain increases gradually, making shoulder motion harder and harder. Pain tends to be worse at night. Frozen: Pain does not worsen, and it may decrease at this stage. The shoulder remains stiff. Thawing: Movement gets easier and may eventually return to normal. Signs and symptoms typically begin gradually, worsen over time and then resolve, usually within one to three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mulligan mobilization technique | Experimental | Other: mulligan mobilization techniqueSustain Posterolateral glide with belt and then told Patient to move in following pattern (internal rotation, external rotation, abduction, wall sliding) |
| muscle energy technique | Active comparator | Other: muscle energy techniquePost facilitation stretch Patient perform isometrics for 15 seconds then therapist rapidly move the shoulder to the end range |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pain in shoulder for at least 3 months
- Unilateral frozen shoulder of stage 3 and 4
- Capsular pattern i.e. (lateral rotation, Abduction, Medial rotation)
Key exclusion criteria (6 listed)
- Secondary capsulitis
- Shoulder injury such as proximal humerus fracture.
- History of Neurological deficit i.e. cervical stenosis, myelopathy.
- Prolong immobilization due to cardiothoracic surgery, neurosurgery.
- Shoulder surgical history such as shoulder arthroplasty.
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 |
|---|---|---|
| muscle energy techniquePost facilitation stretch Patient perform isometrics for 15 seconds then therapist rapidly move the shoulder to the end range | Other | muscle energy technique |
| mulligan mobilization techniqueSustain Posterolateral glide with belt and then told Patient to move in following pattern (internal rotation, external rotation, abduction, wall sliding) | Other | mulligan mobilization technique |
Primary outcome
The Quick Disabilities of the Arm, Shoulder and Hand
Time frame: 4th week
The Quick Disabilities of the Arm, Shoulder and Hand only contains subset of 11 items. it is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated The scores range from 0 (no disability) to 100 (most severe disability).
The Shoulder Pain and Disability Index
Time frame: 4th week
it is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily living requiring the use of the upper extremities. The pain subscale is a composite measure and has 5-items and the Disability subscale is a composite measure and has 8-items. Total pain score (which is composite measure): / 50 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 40) Total disability score (which is composite measure): / 80 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 70) Total Shoulder Pain and Disability score: / 130 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 120) The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Goniometry
Time frame: 4th week
To measure Range of Motion at Shoulder joint.
1 secondary outcome
Numeric pain rating scale
Time frame: 4th week
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 30 Aug 2021.
- Background: PubMed 7319853Goodridge JP. Muscle energy technique: definition, explanation, methods of procedure. J Am Osteopath Assoc. 1981 Dec;81(4):249-54. No abstract available.
- Background: PubMed 23125887Campbell SM, Winkelmann RR, Walkowski S. Osteopathic manipulative treatment: novel application to dermatological disease. J Clin Aesthet Dermatol. 2012 Oct;5(10):24-32.
- Background: PubMed 24284277Jain TK, Sharma NK. The effectiveness of physiotherapeutic interventions in treatment of frozen shoulder/adhesive capsulitis: a systematic review. J Back Musculoskelet Rehabil. 2014;27(3):247-73. doi: 10.3233/BMR-130443.
- Background: PubMed 26304789Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
- Background: PubMed 24078753Jones S, Hanchard N, Hamilton S, Rangan A. A qualitative study of patients' perceptions and priorities when living with primary frozen shoulder. BMJ Open. 2013 Sep 26;3(9):e003452. doi: 10.1136/bmjopen-2013-003452.
- Background: PubMed 11252464Solomonow M, Krogsgaard M. Sensorimotor control of knee stability. A review. Scand J Med Sci Sports. 2001 Apr;11(2):64-80. doi: 10.1034/j.1600-0838.2001.011002064.x.
- Background: PubMed 32202646Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.
- Background: PubMed 23037929Doner G, Guven Z, Atalay A, Celiker R. Evalution of Mulligan's technique for adhesive capsulitis of the shoulder. J Rehabil Med. 2013 Jan;45(1):87-91. doi: 10.2340/16501977-1064.
- Background: PubMed 18802309Nicholson GG. The effects of passive joint mobilization on pain and hypomobility associated with adhesive capsulitis of the shoulder. J Orthop Sports Phys Ther. 1985;6(4):238-46. doi: 10.2519/jospt.1985.6.4.238.
- 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.
Muhammad Sanaullah, MS principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle energy technique and mulligan mobilization 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 3 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 30 Aug 2021. 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?
The Quick Disabilities of the Arm, Shoulder and Hand (time frame: 4th week). The study lists 3 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 NCT04993092, which also lists 9 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 30 Aug 2021.