Stiffness of Shoulder, Not Elsewhere ClassifiedNCT05540301
Sleeper's and Adduction Stretch to Increase Shoulder ROM
A study testing Modified sleeper stretching and Modified cross-body adduction stretch in people with Stiffness of Shoulder, Not Elsewhere Classified, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The study aimed to compare the efficacy of modified sleeper stretch and modified cross-body adduction stretch in improving shoulder internal rotation range of motion and upper limb function. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stiffness of Shoulder, Not Elsewhere Classified
- What is being tested?
- Modified sleeper stretching and Modified cross-body adduction stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Mar 2016to 6 Apr 2017
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Lawn Tennis Players
- Male
- more than 15 degree glenohumeral internal rotation deficiency
Who cannot join
- systemic or metabolic disorders
- a positive test for labral lesions or rotator cuff tears
- a history of recent fracture
- a history of orthopaedic surgery in the upper limbs or cervical region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Modified Sleeper Stretch And Modified Cross-Body Adduction Stretch To Increase Shoulder Internal Rotation Range of Motion In Tennis Players
The study aimed to compare the efficacy of modified sleeper stretch and modified cross-body adduction stretch in improving shoulder internal rotation range of motion and upper limb function. Thirty male lawn tennis players aged between 20 to 35, with more than 150 glenohumeral internal rotation deficiency (GIRD) on the dominant shoulder (compared to the nondominant side) participate in the study and divided into two groups (A and B). Group A received a modified sleeper stretch and group B received a modified cross-body adduction stretch for four weeks, five times per week. The outcome measures were the internal rotation range of motion measured by a universal goniometer and upper limb functions measured by the Disability of the Arm, Shoulder, and Hand (DASH) scale.
- Being tested
- Modified sleeper stretching, Modified cross-body adduction stretch
- Keywords
- Sleeper Stretch, Cross-Body Stretch, Range of Motion, Shoulder, Tennis Players
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified sleeper stretchingOther
Modified sleeper stretching was performed on shoulder joint to increase internal rotation range of motion.
Modified cross-body adduction stretchOther
Modified cross-body adduction stretching was performed on shoulder joint to increase internal rotation range of motion.
| Study group | Role | What they receive |
|---|---|---|
| Modified Sleeper Stretch Group | Experimental | Modified sleeper stretch was performed for four weeks. Receives: Other: Modified sleeper stretching |
| Modified Cross-Body Adduction Stretch Group | Active comparator | Modified cross-body adduction stretch was performed for four weeks. Receives: Other: Modified cross-body adduction stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal rotation range of motion
Internal rotation range of motion (ROM) was measured using the universal goniometer before and after the completion of the intervention. The greater the ROM, the better the prognosis.
Measured: 4 weeks.
Upper limb functions
The Disability of the Arm, Shoulder, and Hand (DASH) scale was used to assess the upper limb functions. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The higher the score, the worse the prognosis.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start8 Mar 2016
- Primary completion23 Jan 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stiffness of Shoulder, Not Elsewhere ClassifiedStudies 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
- Model description
- Two-group two-factor research design was used.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540301
- Sponsor's protocol ID
- 3/2015/MPT
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Modified Sleeper Stretch And Modified Cross-Body Adduction Stretch To Increase Shoulder Internal Rotation Range of Motion In Tennis Players
- ClinicalTrials.gov ID
- NCT05540301
- Acronym / sponsor ID
- 3/2015/MPT
- Keywords
- Sleeper Stretch, Cross-Body Stretch, Range of Motion, Shoulder, Tennis Players
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 23 Jan 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 14 Sep 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 study aimed to compare the efficacy of modified sleeper stretch and modified cross-body adduction stretch in improving shoulder internal rotation range of motion and upper limb function. Thirty male lawn tennis players aged between 20 to 35, with more than 150 glenohumeral internal rotation deficiency (GIRD) on the dominant shoulder (compared to the nondominant side) participate in the study and divided into two groups (A and B). Group A received a modified sleeper stretch and group B received a modified cross-body adduction stretch for four weeks, five times per week. The outcome measures were the internal rotation range of motion measured by a universal goniometer and upper limb functions measured by the Disability of the Arm, Shoulder, and Hand (DASH) scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-group two-factor research design was used.
| Arm | Type | Receives |
|---|---|---|
| Modified Sleeper Stretch Group | Experimental | Other: Modified sleeper stretchingModified sleeper stretch was performed for four weeks. |
| Modified Cross-Body Adduction Stretch Group | Active comparator | Other: Modified cross-body adduction stretchModified cross-body adduction stretch was performed for four weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Lawn Tennis Players
- Male
- more than 15 degree glenohumeral internal rotation deficiency
Key exclusion criteria (4 listed)
- systemic or metabolic disorders
- a positive test for labral lesions or rotator cuff tears
- a history of recent fracture
- a history of orthopaedic surgery in the upper limbs or cervical 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 |
|---|---|---|
| Modified sleeper stretchingModified sleeper stretching was performed on shoulder joint to increase internal rotation range of motion. | Other | Modified Sleeper Stretch Group |
| Modified cross-body adduction stretchModified cross-body adduction stretching was performed on shoulder joint to increase internal rotation range of motion. | Other | Modified Cross-Body Adduction Stretch Group |
Primary outcome
Internal rotation range of motion
Time frame: 4 weeks.
Internal rotation range of motion (ROM) was measured using the universal goniometer before and after the completion of the intervention. The greater the ROM, the better the prognosis.
Upper limb functions
Time frame: 4 weeks.
The Disability of the Arm, Shoulder, and Hand (DASH) scale was used to assess the upper limb functions. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The higher the score, the worse the prognosis.
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 14 Sep 2022.
- Individual participant dataSharing planned: No
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.
Masood Khan, M.P.Th principal investigator
King Saud 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 Modified sleeper stretching and Modified cross-body adduction stretch in people with Stiffness of Shoulder, Not Elsewhere Classified, run by King Saud University at 1 site in Saudi Arabia.
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: finished, as of the sponsor's last update on 14 Sep 2022. 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 Saudi Arabia. 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?
Internal rotation range of motion (time frame: 4 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?
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 14 Sep 2022.