Adhesive CapsulitisNCT04561310
Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients
A study testing Post facilitation stretch and Active release technique in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Post facilitation stretch and Active release technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2020to 30 Jan 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Controlled diabetic patients (random 200-250mg/dl /fasting 120-160mg/dl).
- Grade 2 \& 3 of adhesive capsulitis,
- Pain (NPRS) ranging between 3-10
- Reduced normal shoulder ROM's i.e
- Flexion less than 160 degrees.
- Extension less than 50 degrees.
Show all 9Show fewer
- Abduction less than 170 degrees.
- External rotation less than 80 degrees.
- Internal rotation less than 70 degrees
Who cannot join
- Trauma history of shoulder/surgery.
- Frozen shoulder accompanied with neurological involvement.
- People with any injury or disability of elbow or hand
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Post Facilitation Stretch and Active Release Technique in Adhesive Capsulitis in Diabetic Patients
To determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques
Read the detailed description
There is a very limited literature available Active release technique (ART) and Post Facilitation Stretch (PFS) in frozen shoulder. Additionally there is a very limited literature on the evaluation of ART in comparison with PFS in adhesive capsulitis of diabetic patient. Disease such as rheumatoid arthritis (RA), osteoarthritis (OA) etc that cause stiffness of the shoulder joint also present with altered muscle activity, that in long run becomes one of the main causes of reduces joint range of motion. With this study, we will be able to determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques. This study will also fulfill that research gap and will provide clinicians with an alternative approach in treatment of adhesive capsulitis.
- Conditions
- Adhesive Capsulitis
- Being tested
- Post facilitation stretch, Active release technique
- Keywords
- Shoulder, Pain, Fibrosis, Disability
- Medical subject headings
- Bursitis, Pain, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post facilitation stretchOther
Post facilitation stretch with maitland mobilization Grade I \& II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week.
Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session
Active release techniqueOther
Active release technique with maitland mobilization Grade I \& II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week.
Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session
| Study group | Role | What they receive |
|---|---|---|
| Post facilitation stretch | Experimental | Post facilitation stretch with Maitland mobilization Receives: Other: Post facilitation stretch |
| Active release technique | Active comparator | Active release technique with Maitland mobilization Receives: Other: Active release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain and disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
Each of the 13 items is to be rated with a number from 0 to 10: For the pain score (first 5 items): 0 means no pain and 10 means worst pain imaginable; For the disability score (last 8 items): 0 means no impairment and 10 means the patient requires help to perform that action
Measured: 6th week
The oxford scale
The Oxford Scale is a 0-5 scale which is then recorded as 0/5 or 2/5, sometimes with a + or - sign to indicate more or less power but not sufficient to reduce or increase the number.
Measured: 6th week
Numeric Pain Rating Scale (NPRS)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
Measured: 6th week
ROM Shoulder Flexion
Goniometer is used to measure the range of the motion of the shoulder flexion
Measured: 6th week
ROM Shoulder Extension
Goniometer is used to measure the range of the motion of the shoulder extension
Measured: 6th week
ROM Shoulder Abduction
Goniometer is used to measure the range of the motion of the shoulder Abduction
Measured: 6th week
ROM Shoulder External Rotation
Goniometer is used to measure the range of the motion of the shoulder External Rotation
Measured: 6th week
ROM Shoulder Internal Rotation
Goniometer is used to measure the range of the motion of the shoulder Internal Rotation
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 posted23 Sep 2020
- Study start15 Jun 2020
- Primary completion1 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- 36 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
- NCT04561310
- Sponsor's protocol ID
- REC/00241 Ummal Baneen
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rose PG. Effective Reduction of Adhesive Capsulitis Pain with a Suprascapular Nerve Block Given in a Primary Care Clinic. InConference Highlights (p. 30).
Ewald A. Adhesive capsulitis: a review. Am Fam Physician. 2011 Feb 15;83(4):417-22.
PubMed 21322517Tighe 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 18475240Garcilazo C, Cavallasca JA, Musuruana JL. Shoulder manifestations of diabetes mellitus. Curr Diabetes Rev. 2010 Sep;6(5):334-40. doi: 10.2174/157339910793360824.
PubMed 20701586Hsu CL, Sheu WH. Diabetes and shoulder disorders. J Diabetes Investig. 2016 Sep;7(5):649-51. doi: 10.1111/jdi.12491. Epub 2016 Mar 16. No abstract available.
PubMed 27182002Donatelli R, Ruivo RM, Thurner M, Ibrahim MI. New concepts in restoring shoulder elevation in a stiff and painful shoulder patient. Phys Ther Sport. 2014 Feb;15(1):3-14. doi: 10.1016/j.ptsp.2013.11.001. Epub 2013 Nov 16.
PubMed 24315683Anton HA. Frozen shoulder. Can Fam Physician. 1993 Aug;39:1773-8.
PubMed 8374364Gutierrez Espinoza HJ, Pavez F, Guajardo C, Acosta M. Glenohumeral posterior mobilization versus conventional physiotherapy for primary adhesive capsulitis: a randomized clinical trial. Medwave. 2015 Sep 22;15(8):e6267. doi: 10.5867/medwave.2015.08.6267. English, Spanish.
PubMed 26485477Ravichandran H, Balamurugan J. Effect of proprioceptive neuromuscular facilitation stretch and muscle energy technique in the management of adhesive capsulitis of the shoulder. Saudi Journal of Sports Medicine. 2015 May 1;15(2):170.
Vermeulen HM, Rozing PM, Obermann WR, le Cessie S, Vliet Vlieland TP. Comparison of high-grade and low-grade mobilization techniques in the management of adhesive capsulitis of the shoulder: randomized controlled trial. Phys Ther. 2006 Mar;86(3):355-68.
PubMed 16506872Gupta S, Jaiswal P, Chhabra D. A comparative study between postisometric relaxation and isometric exercises in non-specific neck pain. Journal of exercise science and physiotherapy. 2008;4(2):88.
Kim JH, Lee HS, Park SW. Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J Phys Ther Sci. 2015 Aug;27(8):2461-4. doi: 10.1589/jpts.27.2461. Epub 2015 Aug 21.
PubMed 26357426Shih YF, Liao PW, Lee CS. The immediate effect of muscle release intervention on muscle activity and shoulder kinematics in patients with frozen shoulder: a cross-sectional, exploratory study. BMC Musculoskelet Disord. 2017 Nov 28;18(1):499. doi: 10.1186/s12891-017-1867-8.
PubMed 29183307Noten S, Meeus M, Stassijns G, Van Glabbeek F, Verborgt O, Struyf F. Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):815-25. doi: 10.1016/j.apmr.2015.07.025. Epub 2015 Aug 15.
PubMed 26284892Hung CJ, Hsieh CL, Yang PL, Lin JJ. Relationships between posterior shoulder muscle stiffness and rotation in patients with stiff shoulder. J Rehabil Med. 2010 Mar;42(3):216-20. doi: 10.2340/16501977-0504.
PubMed 20411215
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post Facilitation Stretch and Active Release Technique in Adhesive Capsulitis in Diabetic Patients
- ClinicalTrials.gov ID
- NCT04561310
- Acronym / sponsor ID
- REC/00241 Ummal Baneen
- Conditions
- Adhesive Capsulitis
- Keywords
- Shoulder, Pain, Fibrosis, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 23 Sep 2020 (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.
To determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques
Detailed description
There is a very limited literature available Active release technique (ART) and Post Facilitation Stretch (PFS) in frozen shoulder. Additionally there is a very limited literature on the evaluation of ART in comparison with PFS in adhesive capsulitis of diabetic patient. Disease such as rheumatoid arthritis (RA), osteoarthritis (OA) etc that cause stiffness of the shoulder joint also present with altered muscle activity, that in long run becomes one of the main causes of reduces joint range of motion. With this study, we will be able to determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques. This study will also fulfill that research gap and will provide clinicians with an alternative approach in treatment of adhesive capsulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post facilitation stretch | Experimental | Other: Post facilitation stretchPost facilitation stretch with Maitland mobilization |
| Active release technique | Active comparator | Other: Active release techniqueActive release technique with Maitland mobilization |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Controlled diabetic patients (random 200-250mg/dl /fasting 120-160mg/dl).
- Grade 2 \& 3 of adhesive capsulitis,
- Pain (NPRS) ranging between 3-10
- Reduced normal shoulder ROM's i.e
Key exclusion criteria (3 listed)
- Trauma history of shoulder/surgery.
- Frozen shoulder accompanied with neurological involvement.
- People with any injury or disability of elbow or hand
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 |
|---|---|---|
| Post facilitation stretchPost facilitation stretch with maitland mobilization Grade I \& II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week. Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session | Other | Post facilitation stretch |
| Active release techniqueActive release technique with maitland mobilization Grade I \& II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week. Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session | Other | Active release technique |
Primary outcome
Shoulder pain and disability Index (SPADI)
Time frame: 6th week
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Each of the 13 items is to be rated with a number from 0 to 10: For the pain score (first 5 items): 0 means no pain and 10 means worst pain imaginable; For the disability score (last 8 items): 0 means no impairment and 10 means the patient requires help to perform that action
The oxford scale
Time frame: 6th week
The Oxford Scale is a 0-5 scale which is then recorded as 0/5 or 2/5, sometimes with a + or - sign to indicate more or less power but not sufficient to reduce or increase the number.
Numeric Pain Rating Scale (NPRS)
Time frame: 6th week
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
ROM Shoulder Flexion
Time frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder flexion
ROM Shoulder Extension
Time frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder extension
ROM Shoulder Abduction
Time frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder Abduction
ROM Shoulder External Rotation
Time frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder External Rotation
ROM Shoulder Internal Rotation
Time frame: 6th week
Goniometer is used to measure the range of the motion of the shoulder Internal Rotation
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 24 Mar 2021.
- BackgroundRose PG. Effective Reduction of Adhesive Capsulitis Pain with a Suprascapular Nerve Block Given in a Primary Care Clinic. InConference Highlights (p. 30).
- Background: PubMed 21322517Ewald A. Adhesive capsulitis: a review. Am Fam Physician. 2011 Feb 15;83(4):417-22.
- 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 20701586Garcilazo C, Cavallasca JA, Musuruana JL. Shoulder manifestations of diabetes mellitus. Curr Diabetes Rev. 2010 Sep;6(5):334-40. doi: 10.2174/157339910793360824.
- Background: PubMed 27182002Hsu CL, Sheu WH. Diabetes and shoulder disorders. J Diabetes Investig. 2016 Sep;7(5):649-51. doi: 10.1111/jdi.12491. Epub 2016 Mar 16. No abstract available.
- Background: PubMed 24315683Donatelli R, Ruivo RM, Thurner M, Ibrahim MI. New concepts in restoring shoulder elevation in a stiff and painful shoulder patient. Phys Ther Sport. 2014 Feb;15(1):3-14. doi: 10.1016/j.ptsp.2013.11.001. Epub 2013 Nov 16.
- Background: PubMed 8374364Anton HA. Frozen shoulder. Can Fam Physician. 1993 Aug;39:1773-8.
- Background: PubMed 26485477Gutierrez Espinoza HJ, Pavez F, Guajardo C, Acosta M. Glenohumeral posterior mobilization versus conventional physiotherapy for primary adhesive capsulitis: a randomized clinical trial. Medwave. 2015 Sep 22;15(8):e6267. doi: 10.5867/medwave.2015.08.6267. English, Spanish.
- BackgroundRavichandran H, Balamurugan J. Effect of proprioceptive neuromuscular facilitation stretch and muscle energy technique in the management of adhesive capsulitis of the shoulder. Saudi Journal of Sports Medicine. 2015 May 1;15(2):170.
- Background: PubMed 16506872Vermeulen HM, Rozing PM, Obermann WR, le Cessie S, Vliet Vlieland TP. Comparison of high-grade and low-grade mobilization techniques in the management of adhesive capsulitis of the shoulder: randomized controlled trial. Phys Ther. 2006 Mar;86(3):355-68.
- BackgroundGupta S, Jaiswal P, Chhabra D. A comparative study between postisometric relaxation and isometric exercises in non-specific neck pain. Journal of exercise science and physiotherapy. 2008;4(2):88.
- Background: PubMed 26357426Kim JH, Lee HS, Park SW. Effects of the active release technique on pain and range of motion of patients with chronic neck pain. J Phys Ther Sci. 2015 Aug;27(8):2461-4. doi: 10.1589/jpts.27.2461. Epub 2015 Aug 21.
- 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.
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 Post facilitation stretch and Active release 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 9 inclusion and 3 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 24 Mar 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?
Shoulder pain and disability Index (SPADI) (time frame: 6th week). The study lists 8 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 NCT04561310, which also lists 15 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 24 Mar 2021.