Shoulder Impingement SyndromeNCT06079944
Effects of Progressive Resistance Training Combined With Traditional Physical Therapy in Patients With Shoulder Impingement Syndrome
A study testing Progressive resistance training and Traditional physical therapy in people with Shoulder Impingement Syndrome, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
A randomized control trial will be done on diagnosed Shoulder impingemnet patients with physical therapy screening in Fauji Foundation Hospital Rawalpindi. There is a growing demand on finding treatments which can be more beneficial and can be started early on in the treatment phase, nowadays. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Progressive resistance training and Traditional physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 30 Mar 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders.(Male and Female)
- Young early adulthood with age 20-40 years.
- Diagnosed cases of Shoulder impingement syndrome.
Who cannot join
- Active joint disease (rheumatoid, or any other rheumatological diseases
- Any history of Cardiovascular events
- Any history of upper limb surgery
- Hematological disease.
- Osteoporosis.
- osteomyelitis
Show all 9Show fewer
- Active fractures/ non or mal-union fractures
- Rotator cuff tears
- Adhesive capsulitis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Nida Kiani, DPT.MSNMPT, +923330418548, nida.mushtaq@fui.edu.pk
About this study
A randomized control trial will be done on diagnosed Shoulder impingemnet patients with physical therapy screening in Fauji Foundation Hospital Rawalpindi.
There is a growing demand on finding treatments which can be more beneficial and can be started early on in the treatment phase, nowadays.
Read more
The purpose of the study is to determine the "effects of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome" using the resistance band and multipulley system.
The traditional physical therapy will include hot pack placed on shoulder and neck region for ten minutes, Transcutaneous electrical nerve stimular will be used and the electrodes will be placed on the desired area (shoulder complex) the intensity will be increased manually according to the capacity of the patient and the treatment time will be of 15 minutes, stretching exercises such as doorway stretch and foam roll supine stretch will be done in the hospital for first 3 weeks and the next 3 weeks will be for home exercises moving from 5 repetitions to 20 repetitions for a set of 3. stretch will be hold for 30 seconds
Read the detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effect of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome in terms of strength.
- To determine the effect of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome in terms of pain.
- To determine the effect of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome in terms of range of motion.
1.HYPOTHESIS:
Alternate Hypothesis:
- There is significant effect in the study group in terms of pain with progressive resistance training than in control group with traditional physical therapy in patients with shoulder impingement syndrome.
- There is significant effect in the study group in terms of range of motion with progressive resistance training than in the control group with traditional physical therapy in patients with shoulder impingement syndrome.
- There is significant effect in the study group in terms of strength with progressive resistance training than in the control group with traditional physical therapy in patients with shoulder impingement syndrome.
Null Hypothesis:
- There is no significant effect in the study group in terms of pain with progressive resistance training than in control group with traditional physical therapy in patients with shoulder impingement syndrome.
- There is no significant effect in the study group in terms of range of motion with progressive resistance training than in the control group with traditional physical therapy in patients with shoulder impingement syndrome.
- There is no significant effect in the study group in terms of strength with progressive resistance training than in the control group with traditional physical therapy in patients with shoulder impingement syndrome.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Rehabilitation department, Fauji Foundation Hospital Study duration: 18 months
Selection Criteria:
Inclusion Criteria Both genders (Male and Female) Young early adulthood with age 20-40 years. Diagnosed Cases of Shoulder impingement syndrome.
Exclusion criteria:
Active joint disease (rheumatoid, or any other rheumatological disease) Any history of Cardiovascular events Recent history of upper limb surgery Hematological disease. Osteoporosis. Osteomyelitis Active fractures/ non or mal-union fractures Rotator cuff tears Adhesive capsulitis. Sampling technique: Convenience sampling envelope Method
Outcome Measures:
- Data will be collected on Demographics and general information
- Pain will be assessed with the help of NPRS (numeric pain rating scale Scale)
- Strength will be measured while calculating the repetition maximum
- Range of motion will be calculated by Goniometry
- self rated upper extremity disability will be measured by DASH (disabilities of Arm, shoulder and hand) questionnaire
Study Group (B) = This group will receive TENS+ Hot pack, Pendulum exercises and stretching exercises for first two weeks before moving to the strength training to avoid any damage incase patient is in the inflammatory phase
- 6RM Load will be determined after which resistance band and multipulley system will be used for treatment and treatment will be divided in to a series of 8 repetitions: 25%, 30%, 35%, 40%, and 50% of 6RM over the period of 6 weeks. Speed of movement will be 2 seconds for both the eccentric and concentric phases.
- To strengthen the shoulder muscles patients will perform flexion, extension, medial and lateral rotation using multipulley system.
Resistance training will only be given to the study group. This groups outcome meaures will be assessed at 3 weeks and then 6th week.
Control group (B) =this group will not receive resistance training through resistance band and multipulley, only traditional Physical therapy will be given and their outcomes will be observed at the baseline and then after treatment of 6 weeks.
Data analysis techniques:
Firstly, Informed consent will be taken by the participants. Data will be gathered according to the inclusion criteria mentioned in the study. Screening tests will be applied and if patient reports the following tests positive: Painful Arc Sign, Infraspinatus test, and Hawkin Kennedy then there is a high likelihood ratio of having the disease and if all three tests are negative, there is strong evidence of absence of disease. Tests for other muscles will also be applied that passes through the subacromial space. Pain will be scored using numeric pain rating scale before the assignment of population in both the groups. Convenience sampling will be used to include the participants in either the control group or study group.
Significance of the study:
- Progressive resistance training program for the musculature of the shoulder in patients with shoulder impingement syndrome may prove effective in reducing pain, increasing strength and improving function.
- This study will help the practitioner to use the new treatment options for treating patients with shoulder impingement syndrome.
- The results of the study will add to the literature about the effects of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Progressive resistance training, Traditional physical therapy
- Keywords
- Exercises, Impingement syndrome, Physical therapy , Resistance training, Shoulder pain
- Medical subject headings
- Shoulder Impingement Syndrome, Motor Activity, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingProcedure or surgery
- 6RM Load will be determined after which multipulley system will be used for treatment and treatment will be divided in to two series of 8 repetition:
- 25%, 30%,35%,40%, 50% of 6RM over the period of 6 weeks
- Speed of movement will be 2 seconds for both the eccentric and concentric phases.
- To strengthen the shoulder muscles patients will perform flexion, extension, medial and lateral rotation using multipulley system.
Traditional physical therapyProcedure or surgery
- TENS+ Hot pack
- Pendulum exercises and stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Group A- Control group | Active comparator | Group (A)/ control group Involves participants receiving
1. TENS+ hot pack (10mins)
2. Pendulum exercises and stretching exercises This group will not receive resistance training from 5 repetitions to 20 repetitions of door way stretch (maintained for 30seconds), pendulum exercises and foam roll strtech will be provided over the 6 weeks protocol Receives: Procedure: Traditional physical therapy |
| Group B- Study Group | Experimental | Group (B)/ Experimental group involves participants receiving Traditional l physical therapy for shoulder impingement syndrome for 6 weeks.
1. TENS+ hot pack (10mins)
2. Pendulum exercises and stretching exercises 3-6RM Load will be determined after which multipulley system will be used for treatment and treatment will be divided in to two series of 8 repetition: 25%, 30%,35%,40%, 50% of 6RM over the period of 6 weeks Speed of movement will be 2 seconds for both the eccentric and concentric phases.
To strengthen the shoulder muscles patients will perform flexion, extension, medial and lateral rotation It is a combined treatment so study group will receive both study group and control group intervention Receives: Procedure: Progressive resistance training; Procedure: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity using Numeric pain rating scale (NPRS)
change in the values of pain using Numeric pain rating scale from the base line then week 3 and then to the end of 6 weeks
Measured: 6 weeks
Shoulder range of motion using Goniometer
Shoulder range of motion will be assessed using goniometer in flexion, extension, abduction, external and internal rotation of shoulder for both the study and control group
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 posted12 Oct 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion30 Mar 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 Foundation University IslamabadThe 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
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079944
- Sponsor's protocol ID
- FUI/CTR/2023/18
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Resistance Training Combined With Traditional Physical Therapy in Patients With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06079944
- Acronym / sponsor ID
- FUI/CTR/2023/18
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Exercises, Impingement syndrome, Physical therapy , Resistance training, Shoulder pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 12 Oct 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.
A randomized control trial will be done on diagnosed Shoulder impingemnet patients with physical therapy screening in Fauji Foundation Hospital Rawalpindi.
There is a growing demand on finding treatments which can be more beneficial and can be started early on in the treatment phase, nowadays.
The purpose of the study is to determine the "effects of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome" using the resistance band and multipulley system.
The traditional physical therapy will include hot pack placed on shoulder and neck region for ten minutes, Transcutaneous electrical nerve stimular will be used and the electrodes will be placed on the desired area (shoulder complex) the intensity will be increased manually according to the capacity of the patient and the treatment time will be of 15 minutes, stretching exercises such as doorway stretch and foam roll supine stretch will be done in the hospital for first 3 weeks and the next 3 weeks will be for home exercises moving from 5 repetitions to 20 repetitions for a set of 3. stretch will be hold for 30 seconds
Detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effect of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome in terms of strength.
- To determine the effect of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome in terms of pain.
- To determine the effect of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome in terms of range of motion.
1.HYPOTHESIS:
Alternate Hypothesis:
- There is significant effect in the study group in terms of pain with progressive resistance training than in control group with traditional physical therapy in patients with shoulder impingement syndrome.
- There is significant effect in the study group in terms of range of motion with progressive resistance training than in the control group with traditional physical therapy in patients with shoulder impingement syndrome.
- There is significant effect in the study group in terms of strength with progressive resistance training than in the control group with traditional physical therapy in patients with shoulder impingement syndrome.
Null Hypothesis:
- There is no significant effect in the study group in terms of pain with progressive resistance training than in control group with traditional physical therapy in patients with shoulder impingement syndrome.
- There is no significant effect in the study group in terms of range of motion with progressive resistance training than in the control group with traditional physical therapy in patients with shoulder impingement syndrome.
- There is no significant effect in the study group in terms of strength with progressive resistance training than in the control group with traditional physical therapy in patients with shoulder impingement syndrome.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Rehabilitation department, Fauji Foundation Hospital Study duration: 18 months
Selection Criteria:
Inclusion Criteria Both genders (Male and Female) Young early adulthood with age 20-40 years. Diagnosed Cases of Shoulder impingement syndrome.
Exclusion criteria:
Active joint disease (rheumatoid, or any other rheumatological disease) Any history of Cardiovascular events Recent history of upper limb surgery Hematological disease. Osteoporosis. Osteomyelitis Active fractures/ non or mal-union fractures Rotator cuff tears Adhesive capsulitis. Sampling technique: Convenience sampling envelope Method
Outcome Measures:
- Data will be collected on Demographics and general information
- Pain will be assessed with the help of NPRS (numeric pain rating scale Scale)
- Strength will be measured while calculating the repetition maximum
- Range of motion will be calculated by Goniometry
- self rated upper extremity disability will be measured by DASH (disabilities of Arm, shoulder and hand) questionnaire
Study Group (B) = This group will receive TENS+ Hot pack, Pendulum exercises and stretching exercises for first two weeks before moving to the strength training to avoid any damage incase patient is in the inflammatory phase
- 6RM Load will be determined after which resistance band and multipulley system will be used for treatment and treatment will be divided in to a series of 8 repetitions: 25%, 30%, 35%, 40%, and 50% of 6RM over the period of 6 weeks. Speed of movement will be 2 seconds for both the eccentric and concentric phases.
- To strengthen the shoulder muscles patients will perform flexion, extension, medial and lateral rotation using multipulley system.
Resistance training will only be given to the study group. This groups outcome meaures will be assessed at 3 weeks and then 6th week.
Control group (B) =this group will not receive resistance training through resistance band and multipulley, only traditional Physical therapy will be given and their outcomes will be observed at the baseline and then after treatment of 6 weeks.
Data analysis techniques:
Firstly, Informed consent will be taken by the participants. Data will be gathered according to the inclusion criteria mentioned in the study. Screening tests will be applied and if patient reports the following tests positive: Painful Arc Sign, Infraspinatus test, and Hawkin Kennedy then there is a high likelihood ratio of having the disease and if all three tests are negative, there is strong evidence of absence of disease. Tests for other muscles will also be applied that passes through the subacromial space. Pain will be scored using numeric pain rating scale before the assignment of population in both the groups. Convenience sampling will be used to include the participants in either the control group or study group.
Significance of the study:
- Progressive resistance training program for the musculature of the shoulder in patients with shoulder impingement syndrome may prove effective in reducing pain, increasing strength and improving function.
- This study will help the practitioner to use the new treatment options for treating patients with shoulder impingement syndrome.
- The results of the study will add to the literature about the effects of progressive resistance training combined with traditional physical therapy in patients with shoulder impingement syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A- Control group | Active comparator | Procedure: Traditional physical therapyGroup (A)/ control group Involves participants receiving 1. TENS+ hot pack (10mins) 2. Pendulum exercises and stretching exercises This group will not receive resistance training from 5 repetitions to 20 repetitions of door way stretch (maintained for 30seconds), pendulum exercises and foam roll strtech will be provided over the 6 weeks protocol |
| Group B- Study Group | Experimental | Procedure: Progressive resistance training, Procedure: Traditional physical therapyGroup (B)/ Experimental group involves participants receiving Traditional l physical therapy for shoulder impingement syndrome for 6 weeks. 1. TENS+ hot pack (10mins) 2. Pendulum exercises and stretching exercises 3-6RM Load will be determined after which multipulley system will be used for treatment and treatment will be divided in to two series of 8 repetition: 25%, 30%,35%,40%, 50% of 6RM over the period of 6 weeks Speed of movement will be 2 seconds for both the eccentric and concentric phases. To strengthen the shoulder muscles patients will perform flexion, extension, medial and lateral rotation It is a combined treatment so study group will receive both study group and control group intervention |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders.(Male and Female)
- Young early adulthood with age 20-40 years.
- Diagnosed cases of Shoulder impingement syndrome.
Key exclusion criteria (9 listed)
- Active joint disease (rheumatoid, or any other rheumatological diseases
- Any history of Cardiovascular events
- Any history of upper limb surgery
- Hematological disease.
- Osteoporosis.
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 |
|---|---|---|
| Progressive resistance training* 6RM Load will be determined after which multipulley system will be used for treatment and treatment will be divided in to two series of 8 repetition: * 25%, 30%,35%,40%, 50% of 6RM over the period of 6 weeks * Speed of movement will be 2 seconds for both the eccentric and concentric phases. * To strengthen the shoulder muscles patients will perform flexion, extension, medial and lateral rotation using multipulley system. | Procedure or surgery | Group B- Study Group |
| Traditional physical therapy* TENS+ Hot pack * Pendulum exercises and stretching exercises | Procedure or surgery | Group A- Control group, Group B- Study Group |
Primary outcome
Pain intensity using Numeric pain rating scale (NPRS)
Time frame: 6 weeks
change in the values of pain using Numeric pain rating scale from the base line then week 3 and then to the end of 6 weeks
Shoulder range of motion using Goniometer
Time frame: 6 weeks
Shoulder range of motion will be assessed using goniometer in flexion, extension, abduction, external and internal rotation of shoulder for both the study and control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training and Traditional physical therapy in people with Shoulder Impingement Syndrome, run by Foundation University Islamabad 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 3 inclusion and 9 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 12 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esma Araf, MSKPT (+923105969743, Esmaaraf25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity using Numeric pain rating scale (NPRS) (time frame: 6 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 12 Oct 2023.