Adhesive CapsulitisNCT04852939
Bowen's Technique in Patients With Adhesive Capsulitis
A study testing Bowen's technique and Conventional physical therapy in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will help the physiotherapists in overcoming the challenges and barriers in the treatment. It will also help researchers in acquiring sufficient knowledge for further research on the Bowen technique and its various applications as this technique is not widely applied in the field of physical therapy… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Bowen's technique and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Oct 2020to 10 Jul 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Age 25 to 60 years
- History of worsening shoulder pain
- Painful movement from at least 3 month
- Grade 2 \& 3 adhesive capsulitis
- Both Diabetic and non-diabetic
- Limited Ranges in capsular pattern
Who cannot join
- Fracture
- Trauma
- Dislocation
- Ongoing physical therapy treatment
- Cortisone injection prior 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Bowen's Technique in Patients With Adhesive Capsulitis
This study will help the physiotherapists in overcoming the challenges and barriers in the treatment. It will also help researchers in acquiring sufficient knowledge for further research on the Bowen technique and its various applications as this technique is not widely applied in the field of physical therapy treatment.
Read the detailed description
The application of the Bowen technique, producing significant results, will be opted in treatment for the better, improved, and innovative noninvasive management of Adhesive Capsulitis. This study will help the physiotherapists in overcoming the challenges and barriers in the treatment. It will also help researchers in acquiring sufficient knowledge for further research on the Bowen technique and its various applications as this technique is not widely applied in the field of physical therapy treatment.
- Conditions
- Adhesive Capsulitis
- Being tested
- Bowen's technique, Conventional physical therapy
- Keywords
- Adhesive capsulitis, Shoulder, Pain, Bowen technique
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowen's techniqueOther
Initially, cup move is performed which requires a vertically rolling Bowen move over the posterior border of the deltoid muscle above the axillary crease.
The subject's arm is held flexed at 90 degrees at mid-chest height. Then, the elbow is slowly and passively moved in the direction of the opposite shoulder.
After maximal adduction of the arm, the therapist firmly taps the lateral aspect of the shoulder with the heel of his/her hand.
The arm is then carried back to the original start position, where the therapist gently moves superiorly and slightly laterally over the anterior fibers of the deltoid. The arm is then carefully lowered.
The therapist strives to undertake a minimum of moves and procedures to trigger the body's own self-healing powers and assess how much pressure to use and where and when to perform a move to release the build-up of stress.
40-minute sessions thrice a week for 6 weeks.
Conventional physical therapyOther
- Hot pack and transcutaneous electrical nerve stimulator (TENS) for 15 minutes.
- Pendulum stretch, 10 revolutions.
- Cross body stretch, 4 repetitions.
- Towel stretch/hand behind the back, 4 repetitions.
- Isometric internal and external rotation exercises. 40-minute sessions thrice a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bowen's Technique | Experimental | Bowen's Technique Receives: Other: Bowen's technique |
| Conventional Physical Therapy | Active comparator | Conventional Physical Therapy including stretching and strengthening exercises Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position of joints. Intra-class Correlation Coefficients (ICC≥ 0.94)
Measured: 6th week
Numeric Pain Rating Scale
Numerical Pain Rating Scale (NPRS) the Numerical Rating Scale (NPRS-11) is an 11-points scale for self-report of pain. It is the most commonly used unidimensional pain scale. Interclass correlation coefficient (ICC: 0.74)
Measured: 6th week
Shoulder Pain and Disability Index (SPADI):
self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder. Intra-class correlation coefficient (ICC ≥ 0.89)
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start14 Oct 2020
- Primary completion15 Jun 2021
- Study completion10 Jul 2021
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazish Rafique, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852939
- Sponsor's protocol ID
- REC/00859 Ferwa Tahrim
- Status last verified
- Aug 2021
- First submitted
- 20 Apr 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neviaser AS, Neviaser RJ. Adhesive capsulitis of the shoulder. J Am Acad Orthop Surg. 2011 Sep;19(9):536-42. doi: 10.5435/00124635-201109000-00004.
PubMed 21885699Sathe S, Khurana SK, Damke U, Agrawal PV. To Compare the Effects of Maitland Mobilization with Conventional Physiotherapy in Adhesive Capsulitis. Int J Cur Res Rev| Vol. 2020;12(14).
Ewald A. Adhesive capsulitis: a review. Am Fam Physician. 2011 Feb 15;83(4):417-22.
PubMed 21322517Hand GC, Athanasou NA, Matthews T, Carr AJ. The pathology of frozen shoulder. J Bone Joint Surg Br. 2007 Jul;89(7):928-32. doi: 10.1302/0301-620X.89B7.19097.
PubMed 17673588Nitsure P, Kothari N. THE EFFECTIVENESS OF BOWEN TECHNIQUE AS AN ADJUNCT TO CONVENTIONAL PHYSIOTHERAPY ON PAIN AND FUNCTIONAL OUTCOMES IN SUBJECT WITH ACUTE TRAPEZITIS-A PILOT STUDY. Romanian Journal of Physical Therapy/Revista Romana de Kinetoterapie. 2015;21(36).
Wong PL, Tan HC. A review on frozen shoulder. Singapore Med J. 2010 Sep;51(9):694-7.
PubMed 20938608Marr M, Baker J, Lambon N, Perry J. The effects of the Bowen technique on hamstring flexibility over time: a randomised controlled trial. J Bodyw Mov Ther. 2011 Jul;15(3):281-90. doi: 10.1016/j.jbmt.2010.07.008. Epub 2010 Sep 15.
PubMed 21665103Carter B. A pilot study to evaluate the effectiveness of Bowen technique in the management of clients with frozen shoulder. Complement Ther Med. 2001 Dec;9(4):208-15. doi: 10.1054/ctim.2001.0481.
PubMed 12184347
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bowen's Technique in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT04852939
- Acronym / sponsor ID
- REC/00859 Ferwa Tahrim
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive capsulitis, Shoulder, Pain, Bowen technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 10 Jul 2021 (actual)
- First posted
- 21 Apr 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 help the physiotherapists in overcoming the challenges and barriers in the treatment. It will also help researchers in acquiring sufficient knowledge for further research on the Bowen technique and its various applications as this technique is not widely applied in the field of physical therapy treatment.
Detailed description
The application of the Bowen technique, producing significant results, will be opted in treatment for the better, improved, and innovative noninvasive management of Adhesive Capsulitis. This study will help the physiotherapists in overcoming the challenges and barriers in the treatment. It will also help researchers in acquiring sufficient knowledge for further research on the Bowen technique and its various applications as this technique is not widely applied in the field of physical therapy treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bowen's Technique | Experimental | Other: Bowen's techniqueBowen's Technique |
| Conventional Physical Therapy | Active comparator | Other: Conventional physical therapyConventional Physical Therapy including stretching and strengthening exercises |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both genders
- Age 25 to 60 years
- History of worsening shoulder pain
- Painful movement from at least 3 month
- Grade 2 \& 3 adhesive capsulitis
Key exclusion criteria (5 listed)
- Fracture
- Trauma
- Dislocation
- Ongoing physical therapy treatment
- Cortisone injection prior 3 months
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 |
|---|---|---|
| Bowen's techniqueInitially, cup move is performed which requires a vertically rolling Bowen move over the posterior border of the deltoid muscle above the axillary crease. The subject's arm is held flexed at 90 degrees at mid-chest height. Then, the elbow is slowly and passively moved in the direction of the opposite shoulder. After maximal adduction of the arm, the therapist firmly taps the lateral aspect of the shoulder with the heel of his/her hand. The arm is then carried back to the original start position, where the therapist gently moves superiorly and slightly laterally over the anterior fibers of the deltoid. The arm is then carefully lowered. The therapist strives to undertake a minimum of moves and procedures to trigger the body's own self-healing powers and assess how much pressure to use and where and when to perform a move to release the build-up of stress. 40-minute sessions thrice a week for 6 weeks. | Other | Bowen's Technique |
| Conventional physical therapy* Hot pack and transcutaneous electrical nerve stimulator (TENS) for 15 minutes. * Pendulum stretch, 10 revolutions. * Cross body stretch, 4 repetitions. * Towel stretch/hand behind the back, 4 repetitions. * Isometric internal and external rotation exercises. 40-minute sessions thrice a week for 6 weeks. | Other | Conventional Physical Therapy |
Primary outcome
Goniometer
Time frame: 6th week
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position of joints. Intra-class Correlation Coefficients (ICC≥ 0.94)
Numeric Pain Rating Scale
Time frame: 6th week
Numerical Pain Rating Scale (NPRS) the Numerical Rating Scale (NPRS-11) is an 11-points scale for self-report of pain. It is the most commonly used unidimensional pain scale. Interclass correlation coefficient (ICC: 0.74)
Shoulder Pain and Disability Index (SPADI):
Time frame: 6th week
self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder. Intra-class correlation coefficient (ICC ≥ 0.89)
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 6 Aug 2021.
- Background: PubMed 21885699Neviaser AS, Neviaser RJ. Adhesive capsulitis of the shoulder. J Am Acad Orthop Surg. 2011 Sep;19(9):536-42. doi: 10.5435/00124635-201109000-00004.
- BackgroundSathe S, Khurana SK, Damke U, Agrawal PV. To Compare the Effects of Maitland Mobilization with Conventional Physiotherapy in Adhesive Capsulitis. Int J Cur Res Rev| Vol. 2020;12(14).
- Background: PubMed 21322517Ewald A. Adhesive capsulitis: a review. Am Fam Physician. 2011 Feb 15;83(4):417-22.
- Background: PubMed 17673588Hand GC, Athanasou NA, Matthews T, Carr AJ. The pathology of frozen shoulder. J Bone Joint Surg Br. 2007 Jul;89(7):928-32. doi: 10.1302/0301-620X.89B7.19097.
- BackgroundNitsure P, Kothari N. THE EFFECTIVENESS OF BOWEN TECHNIQUE AS AN ADJUNCT TO CONVENTIONAL PHYSIOTHERAPY ON PAIN AND FUNCTIONAL OUTCOMES IN SUBJECT WITH ACUTE TRAPEZITIS-A PILOT STUDY. Romanian Journal of Physical Therapy/Revista Romana de Kinetoterapie. 2015;21(36).
- Background: PubMed 20938608Wong PL, Tan HC. A review on frozen shoulder. Singapore Med J. 2010 Sep;51(9):694-7.
- Background: PubMed 21665103Marr M, Baker J, Lambon N, Perry J. The effects of the Bowen technique on hamstring flexibility over time: a randomised controlled trial. J Bodyw Mov Ther. 2011 Jul;15(3):281-90. doi: 10.1016/j.jbmt.2010.07.008. Epub 2010 Sep 15.
- Background: PubMed 12184347Carter B. A pilot study to evaluate the effectiveness of Bowen technique in the management of clients with frozen shoulder. Complement Ther Med. 2001 Dec;9(4):208-15. doi: 10.1054/ctim.2001.0481.
- Individual participant dataSharing planned: No
Related trials for Adhesive Capsulitis
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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OMT for Adhesive Capsulitis
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Comparative Effects of Niel Asher Technique and Bowen Technique on Pain, Range of Motion and Functional Disability in Patients With Adhesive Capsulitis.
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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.
Nazish Rafique, MSPT 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 Bowen's technique and Conventional physical 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 7 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 6 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?
Goniometer (time frame: 6th 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 NCT04852939, 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 6 Aug 2021.