Shoulder Impingement SyndromeNCT06407804
Effects of Thrower's Ten and Routine Physical Therapy in Patients With Shoulder Impingement Syndrome
A study testing Thrower's Ten Exercise Program and Routine physical therapy. in people with Shoulder Impingement Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of thrower's ten and routine physical therapy on pain, range of motion and functional disability in patients with shoulder impingement syndrome Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Thrower's Ten Exercise Program and Routine physical therapy.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 10 Nov 2024
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 18-35 years
- Male and female
- Shoulder or neck pain within the prior 6month
- 3 positive tests out of 5: Positive Neer's test, positive Hawkins test, positive Jobe's test, painful arc, and pain on resisted external rotation of the arm.
Who cannot join
- History of surgery of the affected shoulder
- Fractures in around the shoulder
- Neurological disorders leading to altered muscle activity
- Systemic arthritic conditions (RA, Osteoporosis)
- Disorders of the cervical spine
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Johar Pain Relief Center
Lahore, Punjab Province, 54782
Rabiya Noor, Phd, 03344355660, rabiya.noor@riphah.edu.pk
zoya shafqat, MS(OMPT)
About this study
Official title: Effects of Thrower's Ten and Routine Physical Therapy on Pain, Range of Motion and Functional Disability in Patients With Shoulder Impingement Syndrome
To compare the effects of thrower's ten and routine physical therapy on pain, range of motion and functional disability in patients with shoulder impingement syndrome
Read the detailed description
Shoulder impingement is a common cause of shoulder pain. It's also known as impingement syndrome or swimmer's shoulder, since it's common in swimmers. It occurs when there is impingement of tendons or bursa in the shoulder from bones of the shoulder. A randomized clinical trial will be conducted at Ibne Sina Hospital,Multan . Non probability convenience sampling technique will be applied on 46 patients who will be allocated through computerized randomization into group A \& group B to collect data. Group A will be given Throwers ten Program and group B will be given routine physical therapy along with baselines. The study will be completed within the time duration of nine months. Primary Outcome measures of the research will be pain, range of motion,function and disability . Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Thrower's Ten Exercise Program, Routine physical therapy.
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrower's Ten Exercise ProgramOther
Also called Routine physical therapy
No Of Sessions Per Week: 3 Per Weeks for 6 weeks (50 Min per Session) No of repetitions; 2 sets for 10 repetitions with 1 minute rest between sets.
Routine physical therapy.Other
In this, the exercises will be performed in 2 sets and 10 repetitions with 5-10s hold and 30s to 1min rest between repetitions.
No Of Sessions Per Week: 3 Per Weeks for 6 weeks (50 Min Per Session)
| Study group | Role | What they receive |
|---|---|---|
| Thrower's Ten Exercise Program | Experimental | 1. D2 PNF flexion
2. D2 PNF extension
3. Internal rotation
4. External rotation
5. Push ups
6. Press ups Receives: Other: Thrower's Ten Exercise Program |
| Routine physical therapy | Sham comparator | 1. Unilateral bench press
2. Bi lateral shoulder retraction
3. Extension in prone position
4. Neck retraction. Then isometrics will be performed which includes
1. Isometric shoulder internal and external rotation 2. Side lying shoulder external rotation 3. Scapular scaption exercise Receives: Other: Routine physical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is used to assess pain. On an 11-point Numeric scale, 0 represents the least amount of pain (no pain) and 10 Represents the most amount of pain (worst pain)
Measured: 6 weeks
Range of Motion
It is frequently employed as a benchmark technique for the assessment of Range of Motion (ROM) as the main component of all joint motions. The range of mobility of a joint is measured using a device known as a goniometer. Goniometry is the art and science of measuring the joint ranges in every plane of the joint. Short arm and long arm versions of the universal goniometer are available. Goniometric measurements are highly reliable provided measurements are conducted by the same therapist. Shoulder Abduction, Flexion and External rotation range will be taken by a Universal Goniometer.
Measured: 6 weeks
Shoulder pain and disability index (SPADI)
The SPADI (Shoulder Pain and impairment Index) was created to assess current shoulder pain and impairment in an outpatient environment. The SPADI consists of 13 items that assess two domains: a 5-item subscale for pain and an 8-item subscale for disability. The SPADI has since been used in both primary care on mixed diagnosis and surgical patient populations including rotator cuff disease, osteoarthritis, and rheumatoid arthritis, adhesive capsulitis ,joint replacement surgery , and in a large population-based study of shoulder symptoms
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Feb 2024
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407804
- Sponsor's protocol ID
- REC/RCR&AHS/23/01110
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thrower's Ten and Routine Physical Therapy on Pain, Range of Motion and Functional Disability in Patients With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06407804
- Acronym / sponsor ID
- REC/RCR&AHS/23/01110
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Nov 2024 (estimated)
- First posted
- 9 May 2024 (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 compare the effects of thrower's ten and routine physical therapy on pain, range of motion and functional disability in patients with shoulder impingement syndrome
Detailed description
Shoulder impingement is a common cause of shoulder pain. It's also known as impingement syndrome or swimmer's shoulder, since it's common in swimmers. It occurs when there is impingement of tendons or bursa in the shoulder from bones of the shoulder. A randomized clinical trial will be conducted at Ibne Sina Hospital,Multan . Non probability convenience sampling technique will be applied on 46 patients who will be allocated through computerized randomization into group A \& group B to collect data. Group A will be given Throwers ten Program and group B will be given routine physical therapy along with baselines. The study will be completed within the time duration of nine months. Primary Outcome measures of the research will be pain, range of motion,function and disability . Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrower's Ten Exercise Program | Experimental | Other: Thrower's Ten Exercise Program1. D2 PNF flexion 2. D2 PNF extension 3. Internal rotation 4. External rotation 5. Push ups 6. Press ups |
| Routine physical therapy | Sham comparator | Other: Routine physical therapy.1. Unilateral bench press 2. Bi lateral shoulder retraction 3. Extension in prone position 4. Neck retraction. Then isometrics will be performed which includes 1. Isometric shoulder internal and external rotation 2. Side lying shoulder external rotation 3. Scapular scaption exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age group 18-35 years
- Male and female
- Shoulder or neck pain within the prior 6month
- 3 positive tests out of 5: Positive Neer's test, positive Hawkins test, positive Jobe's test, painful arc, and pain on resisted external rotation of the arm.
Key exclusion criteria (5 listed)
- History of surgery of the affected shoulder
- Fractures in around the shoulder
- Neurological disorders leading to altered muscle activity
- Systemic arthritic conditions (RA, Osteoporosis)
- Disorders of the cervical spine
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 |
|---|---|---|
| Thrower's Ten Exercise ProgramAlso: Routine physical therapyNo Of Sessions Per Week: 3 Per Weeks for 6 weeks (50 Min per Session) No of repetitions; 2 sets for 10 repetitions with 1 minute rest between sets. | Other | Thrower's Ten Exercise Program |
| Routine physical therapy.In this, the exercises will be performed in 2 sets and 10 repetitions with 5-10s hold and 30s to 1min rest between repetitions. No Of Sessions Per Week: 3 Per Weeks for 6 weeks (50 Min Per Session) | Other | Routine physical therapy |
Primary outcome
Numeric Pain Rating Scale
Time frame: 6 weeks
The Numeric Pain Rating Scale (NPRS) is used to assess pain. On an 11-point Numeric scale, 0 represents the least amount of pain (no pain) and 10 Represents the most amount of pain (worst pain)
Range of Motion
Time frame: 6 weeks
It is frequently employed as a benchmark technique for the assessment of Range of Motion (ROM) as the main component of all joint motions. The range of mobility of a joint is measured using a device known as a goniometer. Goniometry is the art and science of measuring the joint ranges in every plane of the joint. Short arm and long arm versions of the universal goniometer are available. Goniometric measurements are highly reliable provided measurements are conducted by the same therapist. Shoulder Abduction, Flexion and External rotation range will be taken by a Universal Goniometer.
Shoulder pain and disability index (SPADI)
Time frame: 6 weeks
The SPADI (Shoulder Pain and impairment Index) was created to assess current shoulder pain and impairment in an outpatient environment. The SPADI consists of 13 items that assess two domains: a 5-item subscale for pain and an 8-item subscale for disability. The SPADI has since been used in both primary care on mixed diagnosis and surgical patient populations including rotator cuff disease, osteoarthritis, and rheumatoid arthritis, adhesive capsulitis ,joint replacement surgery , and in a large population-based study of shoulder symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
Related trials for Shoulder Impingement Syndrome
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TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
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Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
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"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
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.
Rabiya Noor, PHD 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 Thrower's Ten Exercise Program and Routine physical therapy. in people with Shoulder Impingement Syndrome, 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 4 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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. 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 Zoya Shafqat, MS-DPT (0336 0670767, Zoyabatool100@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 6 weeks). 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?
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 May 2024.