Frozen ShoulderHSRFSRCTNCT05466435
Heavy Slow Resistance Training in Adults With Frozen Shoulder
A study testing Heavy Slow Resistance in people with Frozen Shoulder, run by Ministry of Health, Kuwait.
Trial summary
The aim of the study is to evaluate the efficacy of Heavy Slow Resistance exercise in patients diagnosed with frozen shoulder using randomized controlled trial design Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Heavy Slow Resistance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Aug 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral painful, restricted active and passive range of motion of the shoulder, with loss of passive external rotation of at least 50% compared to opposite side at 0 deg of abduction
- Symptoms present for at least 3 months
- Normal x-rays on anteroposterior, axillary and lateral views
Who cannot join
- Severe degeneration, or trauma involving the shoulder
- Inflammatory joint disease affecting the shoulder.
- Pain or disorders of the cervical spine, elbow, wrist, or hand
- Stroke or peripheral nerve neuropathy Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.
Trial locations and contacts
No sites are listed yet.
Najla Alsiri, Ph.D contact
About this study
Official title: Efficacy of Heavy Slow Resistance Training in Adults With Frozen Shoulder- a Double Blind Randomised Controlled Trial
The aim of the study is to evaluate the efficacy of Heavy Slow Resistance exercise in patients diagnosed with frozen shoulder using randomized controlled trial design
- Conditions
- Frozen Shoulder
- Being tested
- Heavy Slow Resistance, Control group
- Keywords
- Frozen shoulder, Heavy slow resistance, Isometrics, Eccentric exercise, Muscle guarding
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy Slow ResistanceOther
Heavy slow resistance exercise will be given twice a week for 12 weeks along with traditional physical therapy program
Control groupOther
Traditional physical therapy program only will be given twice a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Heavy Slow Resistance group | Experimental | Heavy slow resistance exercise will be given along with traditional physical therapy program Receives: Other: Heavy Slow Resistance; Other: Control group |
| Control group | Placebo comparator | Traditional physical therapy program will be given to the control group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion measurement for external rotation and abduction using clinometer application at week 12
The smart phone clinometer is a validated tool to measure range of motion
Measured: week 12 from baseline measurement
Secondary outcomes (3)
Quick DASH(Quick Disabilities of the of Arm Shoulder and Hand)
Quick DASH is an 11 item questionnaire to measure physical function and symptoms in people presenting with one or more disabilities of the arm, shoulder, and hand. The higher the score from 0 to 100 scale the higher the disability.
Measured: week 12 from baseline measurement
12-Item Short Form Health Survey (SF-12)
SF-12 is a 12 item ,self-reported outcome measure for assessing quality of life.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: week 12 from baseline measurement
The Oxford Shoulder Score(OSS)
The Oxford Shoulder Score is validated tool for measuring pain and disability caused by shoulder pathology. It has 12 items with a score ranging from 0 to 48 with 48 being the best outcome.
Measured: week 12 from baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study startAug 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- 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, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Responsible party
- Principal investigator, N.A.RAFI AHMED, Ministry of Health, Kuwait
- Investigators
- Rafi Ahmed, MPT, Principal investigator, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466435
- Sponsor's protocol ID
- 121
- Acronym
- HSRFSRCT
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request.
Publications
Jurgel J, Rannama L, Gapeyeva H, Ereline J, Kolts I, Paasuke M. Shoulder function in patients with frozen shoulder before and after 4-week rehabilitation. Medicina (Kaunas). 2005;41(1):30-8.
PubMed 15687748Mao CY, Jaw WC, Cheng HC. Frozen shoulder: correlation between the response to physical therapy and follow-up shoulder arthrography. Arch Phys Med Rehabil. 1997 Aug;78(8):857-9. doi: 10.1016/s0003-9993(97)90200-8.
PubMed 9344306Bulgen DY, Binder AI, Hazleman BL, Dutton J, Roberts S. Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens. Ann Rheum Dis. 1984 Jun;43(3):353-60. doi: 10.1136/ard.43.3.353.
PubMed 6742895Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/
PubMed 29489251Neviaser JS. Adhesive capsulitis and the stiff and painful shoulder. Orthop Clin North Am. 1980 Apr;11(2):327-31.
PubMed 7001312Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. doi: 10.11622/smedj.2017107.
PubMed 29242941Page MJ, Green S, Kramer S, Johnston RV, McBain B, Chau M, Buchbinder R. Manual therapy and exercise for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014 Aug 26;2014(8):CD011275. doi: 10.1002/14651858.CD011275.
PubMed 25157702Johnson AJ, Godges JJ, Zimmerman GJ, Ounanian LL. The effect of anterior versus posterior glide joint mobilization on external rotation range of motion in patients with shoulder adhesive capsulitis. J Orthop Sports Phys Ther. 2007 Mar;37(3):88-99. doi: 10.2519/jospt.2007.2307.
PubMed 17416123Diercks RL, Stevens M. Gentle thawing of the frozen shoulder: a prospective study of supervised neglect versus intensive physical therapy in seventy-seven patients with frozen shoulder syndrome followed up for two years. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):499-502. doi: 10.1016/j.jse.2004.03.002.
PubMed 15383804Yoon SH, Lee HY, Lee HJ, Kwack KS. Optimal dose of intra-articular corticosteroids for adhesive capsulitis: a randomized, triple-blind, placebo-controlled trial. Am J Sports Med. 2013 May;41(5):1133-9. doi: 10.1177/0363546513480475. Epub 2013 Mar 18.
PubMed 23507791Celik D, Kaya Mutlu E. Does adding mobilization to stretching improve outcomes for people with frozen shoulder? A randomized controlled clinical trial. Clin Rehabil. 2016 Aug;30(8):786-94. doi: 10.1177/0269215515597294. Epub 2015 Jul 30.
PubMed 26229109Maund E, Craig D, Suekarran S, Neilson A, Wright K, Brealey S, Dennis L, Goodchild L, Hanchard N, Rangan A, Richardson G, Robertson J, McDaid C. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2012;16(11):1-264. doi: 10.3310/hta16110.
PubMed 22405512Rangan 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 33010843Pruimboom L, van Dam AC. Chronic pain: a non-use disease. Med Hypotheses. 2007;68(3):506-11. doi: 10.1016/j.mehy.2006.08.036. Epub 2006 Oct 30.
PubMed 17071012Donatelli 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 24315683
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Heavy Slow Resistance Training in Adults With Frozen Shoulder- a Double Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05466435
- Acronym / sponsor ID
- HSRFSRCT / 121
- Conditions
- Frozen Shoulder
- Keywords
- Frozen shoulder, Heavy slow resistance, Isometrics, Eccentric exercise, Muscle guarding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 20 Jul 2022 (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 the study is to evaluate the efficacy of Heavy Slow Resistance exercise in patients diagnosed with frozen shoulder using randomized controlled trial design
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy Slow Resistance group | Experimental | Other: Heavy Slow Resistance, Other: Control groupHeavy slow resistance exercise will be given along with traditional physical therapy program |
| Control group | Placebo comparator | Other: Control groupTraditional physical therapy program will be given to the control group |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral painful, restricted active and passive range of motion of the shoulder, with loss of passive external rotation of at least 50% compared to opposite side at 0 deg of abduction
- Symptoms present for at least 3 months
- Normal x-rays on anteroposterior, axillary and lateral views
Key exclusion criteria (4 listed)
- Severe degeneration, or trauma involving the shoulder
- Inflammatory joint disease affecting the shoulder.
- Pain or disorders of the cervical spine, elbow, wrist, or hand
- Stroke or peripheral nerve neuropathy Injection with corticosteroids in the affected shoulder in the preceding 4 weeks.
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 |
|---|---|---|
| Heavy Slow ResistanceHeavy slow resistance exercise will be given twice a week for 12 weeks along with traditional physical therapy program | Other | Heavy Slow Resistance group |
| Control groupTraditional physical therapy program only will be given twice a week for 12 weeks | Other | Control group, Heavy Slow Resistance group |
Primary outcome
Range of motion measurement for external rotation and abduction using clinometer application at week 12
Time frame: week 12 from baseline measurement
The smart phone clinometer is a validated tool to measure range of motion
3 secondary outcomes
Quick DASH(Quick Disabilities of the of Arm Shoulder and Hand)
Time frame: week 12 from baseline measurement
12-Item Short Form Health Survey (SF-12)
Time frame: week 12 from baseline measurement
The Oxford Shoulder Score(OSS)
Time frame: week 12 from baseline measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 15687748Jurgel J, Rannama L, Gapeyeva H, Ereline J, Kolts I, Paasuke M. Shoulder function in patients with frozen shoulder before and after 4-week rehabilitation. Medicina (Kaunas). 2005;41(1):30-8.
- Background: PubMed 9344306Mao CY, Jaw WC, Cheng HC. Frozen shoulder: correlation between the response to physical therapy and follow-up shoulder arthrography. Arch Phys Med Rehabil. 1997 Aug;78(8):857-9. doi: 10.1016/s0003-9993(97)90200-8.
- Background: PubMed 6742895Bulgen DY, Binder AI, Hazleman BL, Dutton J, Roberts S. Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens. Ann Rheum Dis. 1984 Jun;43(3):353-60. doi: 10.1136/ard.43.3.353.
- Background: PubMed 29489251Mezian K, Coffey R, Chang KV. Frozen Shoulder. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482162/
- Background: PubMed 7001312Neviaser JS. Adhesive capsulitis and the stiff and painful shoulder. Orthop Clin North Am. 1980 Apr;11(2):327-31.
- Background: PubMed 29242941Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. doi: 10.11622/smedj.2017107.
- Background: PubMed 25157702Page MJ, Green S, Kramer S, Johnston RV, McBain B, Chau M, Buchbinder R. Manual therapy and exercise for adhesive capsulitis (frozen shoulder). Cochrane Database Syst Rev. 2014 Aug 26;2014(8):CD011275. doi: 10.1002/14651858.CD011275.
- Background: PubMed 17416123Johnson AJ, Godges JJ, Zimmerman GJ, Ounanian LL. The effect of anterior versus posterior glide joint mobilization on external rotation range of motion in patients with shoulder adhesive capsulitis. J Orthop Sports Phys Ther. 2007 Mar;37(3):88-99. doi: 10.2519/jospt.2007.2307.
- Background: PubMed 15383804Diercks RL, Stevens M. Gentle thawing of the frozen shoulder: a prospective study of supervised neglect versus intensive physical therapy in seventy-seven patients with frozen shoulder syndrome followed up for two years. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):499-502. doi: 10.1016/j.jse.2004.03.002.
- Background: PubMed 23507791Yoon SH, Lee HY, Lee HJ, Kwack KS. Optimal dose of intra-articular corticosteroids for adhesive capsulitis: a randomized, triple-blind, placebo-controlled trial. Am J Sports Med. 2013 May;41(5):1133-9. doi: 10.1177/0363546513480475. Epub 2013 Mar 18.
- Background: PubMed 26229109Celik D, Kaya Mutlu E. Does adding mobilization to stretching improve outcomes for people with frozen shoulder? A randomized controlled clinical trial. Clin Rehabil. 2016 Aug;30(8):786-94. doi: 10.1177/0269215515597294. Epub 2015 Jul 30.
- Background: PubMed 22405512Maund E, Craig D, Suekarran S, Neilson A, Wright K, Brealey S, Dennis L, Goodchild L, Hanchard N, Rangan A, Richardson G, Robertson J, McDaid C. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2012;16(11):1-264. doi: 10.3310/hta16110.
- Individual participant dataSharing planned: Yes. Data will be available on request.
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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.
Najla Alsiri, Ph.D contact
Rafi Ahmed, MPT principal investigator
Ministry of Health, Kuwait
Questions about this trial
What is this clinical trial studying?
A study testing Heavy Slow Resistance in people with Frozen Shoulder, run by Ministry of Health, Kuwait.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafi Ahmed, MPT (00965-67667808, rafithepainpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion measurement for external rotation and abduction using clinometer application at week 12 (time frame: week 12 from baseline measurement). 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 NCT05466435, which also lists 30 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 20 Jul 2022.