Glenohumeral Internal Rotation DeficitNCT05761990
Novel Stretching Versus Post Isometric Relaxation Techniques On Shoulder Disability In Athletes
A study testing POST ISOMTERIC RELAXATION TECHNIQUE and NOVEL STRETCHING in people with Glenohumeral Internal Rotation Deficit, run by Riphah International University at 1 site in Pakistan.
Trial summary
It was a randomized control trial in which thirty (30) participants having GRID, age between 20-40 years were randomly allocated into two groups i-e NS (Novel stretching) Group (30) and PIR (posterior isometric relaxation techniques) Group (30), February 2022 to March 2022.PIR group received the posterior isometric… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Glenohumeral Internal Rotation Deficit
- What is being tested?
- POST ISOMTERIC RELAXATION TECHNIQUE and NOVEL STRETCHING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Jul 2022to 17 Sep 2022
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female
- Between the ages of 18 and 40
- Athletes with glenohumeral internal deficit
- Basketball, tennis, javelin, squash, swimmers, volleyball, and weightlifter
- participated in local and regional sporting events
- showed a 10° or higher variation in Internal rotation range of motion between shoulders (dominant versus non-dominant)
Who cannot join
- Footballer, cricketer, and hockey player
- Recovering from extensive shoulder and elbow surgery that was performed three months ago.
- presently undergoing medical intervention for the shoulder
- Suffer from a life-threatening illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of A Novel Stretching Versus Post Isometric Relaxation Techniques On Shoulder Pain, Range Of Motion And Disability In Overhead Athletes With Glenohumeral Internal Rotation Deficits
It was a randomized control trial in which thirty (30) participants having GRID, age between 20-40 years were randomly allocated into two groups i-e NS (Novel stretching) Group (30) and PIR (posterior isometric relaxation techniques) Group (30), February 2022 to March 2022.PIR group received the posterior isometric relaxation techniques (three times a week for one month) and NS group received the Novel stretching (three times a week for one month). IR ROM was measured with a goniometer while pain was measured with Numeric Pain Rating Scale intervention and disability of arm, shoulder and hand was measured with DASH score before, immediately, and at week 4 post intervention.
- Conditions
- Glenohumeral Internal Rotation Deficit
- Being tested
- POST ISOMTERIC RELAXATION TECHNIQUE, NOVEL STRETCHING
- Keywords
- range of motion,pain,shoulder,stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POST ISOMTERIC RELAXATION TECHNIQUEOther
POST ISOMETRIC RELAXATION TECHNIQUES
- Stretching the hypertonic muscle to the point when movement resistance is initially felt or just past the point of discomfort.
- For 5 to 10 seconds, a submaximal (10-20%) hypertonic muscle contraction is carried out away from the barrier while resistance is supplied in the other side. To help with this, the individual should breathe in.
- The individual is told to relax while breathing after the isometric contraction. After then, until the next barrier is reached, a gentle stretch is employed to pick up the slack.
- Starting with this new barrier, the procedure is carried out two or three more times.
NOVEL STRETCHINGOther
NOVEL STRETCHING The NS will be performed in a supine posture for Group B participants. Participants will be instructed to open their knees while wearing a resistance band around their knees. Participant will be instructed to bridge as high as he can while keeping his shoulders 90 ° abducted and his elbows 90 ° flexed. By lifting the body weight upward, the bridging motion pins the scapula's medial border against the thorax without immediately squeezing or constricting the posterior shoulder bones. This position is thought to provide more flexibility of mobility while causing less discomfort. The subjects were instructed to hold this position while tightening or "squeezing" their gluteal muscles. They were also instructed to stretch by jerkily turning their shoulders inward as far as possible. Using the second hand, the stretch was pushed forward to the point of mild discomfort while contraction was maintained.
| Study group | Role | What they receive |
|---|---|---|
| POST ISOMTERIC RELAXATION TECHNIQUES | Experimental | Participants in Group A will instruct to perform the PIR techniques
These steps are taken when using the PIR approach:
* Stretching the hypertonic muscle to the point when movement resistance is initially felt or just past the point of discomfort.
* For 5 to 10 seconds, a submaximal (10-20%) hypertonic muscle contraction is carried out away from the barrier while resistance is supplied in the other side. To help with this, the individual should breathe in.
* The individual is told to relax while breathing after the isometric contraction. After then, until the next barrier is reached, a gentle stretch is employed to pick up the slack.
* Starting with this new barrier, the procedure is carried out two or three more times. Receives: Other: POST ISOMTERIC RELAXATION TECHNIQUE |
| NOVEL STRETCHING | Experimental | The NS will be performed in a supine posture for Group B participants. Participants will be instructed to open their knees while wearing a resistance band around their knees. Participant will be instructed to bridge as high as he can while keeping his shoulders 90 ° abducted and his elbows 90 ° flexed. By lifting the body weight upward, the bridging motion pins the scapula's medial border against the thorax without immediately squeezing or constricting the posterior shoulder bones. This position is thought to provide more flexibility of mobility while causing less discomfort. The subjects were instructed to hold this position while tightening or "squeezing" their gluteal muscles. They were also instructed to stretch by jerkily turning their shoulders inward as far as possible. Using the second hand, the stretch was pushed forward to the point of mild discomfort while contraction was maintained. Receives: Other: NOVEL STRETCHING |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric pain rating scale
A respondent uses the Numeric pain rating scale, a numerical variant of the visual analogue scale (VAS), to select a whole number (0-10 integers) that best captures the severity of their pain.
Measured: 4weeks
RANGE OF MOTION
The ROM is measured by GONIOMETER
Measured: 4 weeks
Disability of arm,shoulder and hand score
The DASH is a 30-item questionnaire that offers response options using 5-point Likert scales. Scores vary from 0 (no disability) to 100 (complete disability) (most severe disability). This score was created to help patients with any upper-limb musculoskeletal problem
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 posted9 Mar 2023
- Study start17 Jul 2022
- Primary completion17 Sep 2022
- Study completion17 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glenohumeral Internal Rotation DeficitStudies 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
- POSTERIOR ISOMETRIC TECHNIQUES * For 5 to 10 seconds, a submaximal (10-20%) hypertonic muscle contraction is carried out away from the barrier while resistance is supplied in the other side. * The individual is told to relax while breathing after the isometric contraction. After then, until the next barrier is reached, a gentle stretch is employed to pick up the slack. NOVEL STRETCHING TECHNIQUE The NS will be performed in a supine posture for Group B participants. Participants will be instructed to open their knees while wearing a resistance band around their knees. Participant will be instructed to bridge as high as he can while keeping his shoulders 90 ° abducted and his elbows 90 ° flexed. By lifting the body weight upward, the bridging motion pins the scapula's medial border against the thorax without immediately squeezing or constricting the posterior shoulder bones.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761990
- Sponsor's protocol ID
- REC/RCR & AHS/22/0412
- Status last verified
- Mar 2023
- First submitted
- 24 Nov 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lacheta L, Horan MP, Nolte PC, Goldenberg BT, Dekker TJ, Millett PJ. SLAP Repair Versus Subpectoral Biceps Tenodesis for Isolated SLAP Type 2 Lesions in Overhead Athletes Younger Than 35 Years: Comparison of Minimum 2-Year Outcomes. Orthop J Sports Med. 2022 Jun 21;10(6):23259671221105239. doi: 10.1177/23259671221105239. eCollection 2022 Jun.
PubMed 35757237Jung JW, Kim YK. Scapular Dyskinesis in Elite Boxers with Neck Disability and Shoulder Malfunction. Medicina (Kaunas). 2021 Dec 9;57(12):1347. doi: 10.3390/medicina57121347.
PubMed 34946291
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of A Novel Stretching Versus Post Isometric Relaxation Techniques On Shoulder Pain, Range Of Motion And Disability In Overhead Athletes With Glenohumeral Internal Rotation Deficits
- ClinicalTrials.gov ID
- NCT05761990
- Acronym / sponsor ID
- REC/RCR & AHS/22/0412
- Conditions
- Glenohumeral Internal Rotation Deficit
- Keywords
- range of motion,pain,shoulder,stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 17 Sep 2022 (actual)
- Study completion
- 17 Sep 2022 (actual)
- First posted
- 9 Mar 2023 (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.
It was a randomized control trial in which thirty (30) participants having GRID, age between 20-40 years were randomly allocated into two groups i-e NS (Novel stretching) Group (30) and PIR (posterior isometric relaxation techniques) Group (30), February 2022 to March 2022.PIR group received the posterior isometric relaxation techniques (three times a week for one month) and NS group received the Novel stretching (three times a week for one month). IR ROM was measured with a goniometer while pain was measured with Numeric Pain Rating Scale intervention and disability of arm, shoulder and hand was measured with DASH score before, immediately, and at week 4 post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- POSTERIOR ISOMETRIC TECHNIQUES * For 5 to 10 seconds, a submaximal (10-20%) hypertonic muscle contraction is carried out away from the barrier while resistance is supplied in the other side. * The individual is told to relax while breathing after the isometric contraction. After then, until the next barrier is reached, a gentle stretch is employed to pick up the slack. NOVEL STRETCHING TECHNIQUE The NS will be performed in a supine posture for Group B participants. Participants will be instructed to open their knees while wearing a resistance band around their knees. Participant will be instructed to bridge as high as he can while keeping his shoulders 90 ° abducted and his elbows 90 ° flexed. By lifting the body weight upward, the bridging motion pins the scapula's medial border against the thorax without immediately squeezing or constricting the posterior shoulder bones.
| Arm | Type | Receives |
|---|---|---|
| POST ISOMTERIC RELAXATION TECHNIQUES | Experimental | Other: POST ISOMTERIC RELAXATION TECHNIQUEParticipants in Group A will instruct to perform the PIR techniques These steps are taken when using the PIR approach: * Stretching the hypertonic muscle to the point when movement resistance is initially felt or just past the point of discomfort. * For 5 to 10 seconds, a submaximal (10-20%) hypertonic muscle contraction is carried out away from the barrier while resistance is supplied in the other side. To help with this, the individual should breathe in. * The individual is told to relax while breathing after the isometric contraction. After then, until the next barrier is reached, a gentle stretch is employed to pick up the slack. * Starting with this new barrier, the procedure is carried out two or three more times. |
| NOVEL STRETCHING | Experimental | Other: NOVEL STRETCHINGThe NS will be performed in a supine posture for Group B participants. Participants will be instructed to open their knees while wearing a resistance band around their knees. Participant will be instructed to bridge as high as he can while keeping his shoulders 90 ° abducted and his elbows 90 ° flexed. By lifting the body weight upward, the bridging motion pins the scapula's medial border against the thorax without immediately squeezing or constricting the posterior shoulder bones. This position is thought to provide more flexibility of mobility while causing less discomfort. The subjects were instructed to hold this position while tightening or "squeezing" their gluteal muscles. They were also instructed to stretch by jerkily turning their shoulders inward as far as possible. Using the second hand, the stretch was pushed forward to the point of mild discomfort while contraction was maintained. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female
- Between the ages of 18 and 40
- Athletes with glenohumeral internal deficit
- Basketball, tennis, javelin, squash, swimmers, volleyball, and weightlifter
- participated in local and regional sporting events
Key exclusion criteria (4 listed)
- Footballer, cricketer, and hockey player
- Recovering from extensive shoulder and elbow surgery that was performed three months ago.
- presently undergoing medical intervention for the shoulder
- Suffer from a life-threatening illness
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 ISOMTERIC RELAXATION TECHNIQUEPOST ISOMETRIC RELAXATION TECHNIQUES * Stretching the hypertonic muscle to the point when movement resistance is initially felt or just past the point of discomfort. * For 5 to 10 seconds, a submaximal (10-20%) hypertonic muscle contraction is carried out away from the barrier while resistance is supplied in the other side. To help with this, the individual should breathe in. * The individual is told to relax while breathing after the isometric contraction. After then, until the next barrier is reached, a gentle stretch is employed to pick up the slack. * Starting with this new barrier, the procedure is carried out two or three more times. | Other | POST ISOMTERIC RELAXATION TECHNIQUES |
| NOVEL STRETCHINGNOVEL STRETCHING The NS will be performed in a supine posture for Group B participants. Participants will be instructed to open their knees while wearing a resistance band around their knees. Participant will be instructed to bridge as high as he can while keeping his shoulders 90 ° abducted and his elbows 90 ° flexed. By lifting the body weight upward, the bridging motion pins the scapula's medial border against the thorax without immediately squeezing or constricting the posterior shoulder bones. This position is thought to provide more flexibility of mobility while causing less discomfort. The subjects were instructed to hold this position while tightening or "squeezing" their gluteal muscles. They were also instructed to stretch by jerkily turning their shoulders inward as far as possible. Using the second hand, the stretch was pushed forward to the point of mild discomfort while contraction was maintained. | Other | NOVEL STRETCHING |
Primary outcome
numeric pain rating scale
Time frame: 4weeks
A respondent uses the Numeric pain rating scale, a numerical variant of the visual analogue scale (VAS), to select a whole number (0-10 integers) that best captures the severity of their pain.
RANGE OF MOTION
Time frame: 4 weeks
The ROM is measured by GONIOMETER
Disability of arm,shoulder and hand score
Time frame: 4 weeks
The DASH is a 30-item questionnaire that offers response options using 5-point Likert scales. Scores vary from 0 (no disability) to 100 (complete disability) (most severe disability). This score was created to help patients with any upper-limb musculoskeletal problem
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 9 Mar 2023.
- Background: PubMed 35757237Lacheta L, Horan MP, Nolte PC, Goldenberg BT, Dekker TJ, Millett PJ. SLAP Repair Versus Subpectoral Biceps Tenodesis for Isolated SLAP Type 2 Lesions in Overhead Athletes Younger Than 35 Years: Comparison of Minimum 2-Year Outcomes. Orthop J Sports Med. 2022 Jun 21;10(6):23259671221105239. doi: 10.1177/23259671221105239. eCollection 2022 Jun.
- Background: PubMed 34946291Jung JW, Kim YK. Scapular Dyskinesis in Elite Boxers with Neck Disability and Shoulder Malfunction. Medicina (Kaunas). 2021 Dec 9;57(12):1347. doi: 10.3390/medicina57121347.
- 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.
Muhammad Sanaullah, MS 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 ISOMTERIC RELAXATION TECHNIQUE and NOVEL STRETCHING in people with Glenohumeral Internal Rotation Deficit, 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 6 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 9 Mar 2023. 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?
numeric pain rating scale (time frame: 4weeks). 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 NCT05761990, which also lists 2 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 9 Mar 2023.