Shoulder ImpingementNCT04967911
Effects of PNF on Shoulder Pain in Paraplegic Manual Wheel Chair Users
A study testing Rhythmic stabilization exercises and conventional treatment in people with Shoulder Impingement, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project was a Randomized control trial conducted to check the Effects of Proprioceptive Neuromuscular Facilitation on Shoulder Pain due to chronic impingement syndrome in paraplegic Manual Wheelchair users after Spinal Cord Injury so that we can have best treatment option for patients with shoulder pain due to… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- Rhythmic stabilization exercises and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Nov 2020to 30 Jun 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old paraplegic manual wheel chair users after spinal cord injury.
- Those having level of injury from C7-T12
- Patients who are using wheelchair from more than one year.
- Pain perceived region of one or both Shoulder from last three months or more
- Pain without radicular symptoms radiating to whole upper limbs.
- Wheelchair propulsion in activities of daily living,
- Individuals with positive Neer's test and Hawkins-Kennedy test
Who cannot join
- Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc.
- Any dislocation ,muscular tear and acute problem of shoulder.
- Presented with a diagnosis of cervical spinal stenosis, exhibited bilateral upper extremity symptoms
- Any recent surgery of the shoulder
- Individuals using other mobility devices with wheelchair.
- Individuals with primary impingement
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Mansoora hospital, Lahore, Spine welfare centre, Social security hosital
Lahore, Punjab Province
About this study
Official title: Effects of Propioceptive Neuromuscular Facilitation Technique on Shoulder Pain in Paraplegic Manual Wheel Chair Users After Spinal Cord Injury
This project was a Randomized control trial conducted to check the Effects of Proprioceptive Neuromuscular Facilitation on Shoulder Pain due to chronic impingement syndrome in paraplegic Manual Wheelchair users after Spinal Cord Injury so that we can have best treatment option for patients with shoulder pain due to manual wheelchair usage. duration was of 6months,convenient sampling was done, subject following eligibility criteria from Spine welfare trust center, Nawaz Sharif social security Hospital were randomly allocated in two groups via lottery method, Group A participants were given baseline treatment along with PNF exercises , Group B participants were given baseline treatment upto 6 weeks and 3 sessions per, post intervention assessment was done after 6 weeks, by self-generated questionnaire (WUSPI) wheel chair users shoulder pain index, (SRQ) Shoulder rating questionnaire and physical assessment by 2 special test was done, data was analyzed by using SPSS version 25.
Read the detailed description
In paraplegic manual wheelchair users Shoulder pain is most common problem after spinal cord injury. Due to wheelchair propulsion, weight relief task and other household activities repetitive load induced on upper limb and put substantial load in particular on shoulder.In spinal cord injured patients shoulder pain is because of over use of upper limb and shoulder during wheelchair related activities and personal care activities. less stability and slight muscle mass leads toward pain in their life at some point because of Muscular imbalance and later on shoulder secondary impingement syndrome. This study compared the rhythmic stabilization technique from PNF exercises with conventional treatment on experimental and control group to see the difference in reduction of pain and disability.
- Conditions
- Shoulder Impingement
- Being tested
- Rhythmic stabilization exercises, conventional treatment
- Keywords
- Spinal cord injury, wheelchair users, Shoulder pain, PNF
- Medical subject headings
- Shoulder Impingement Syndrome, Spinal Cord Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic stabilization exercisesOther
PNF techniques and Conventional Treatment:
Experimental group received rhythmical Stabilization Technique on shoulder joint on all shoulder movements up to 1 minute in supine position For stability of joint ,re-establish dynamic rotator cuff stability and to enhance MS strength and decrease pain.
Conventional Treatment: heating pad for 15 minutes, TENS (Transcutaneous Electrical Nerve Stimulation) and after that shoulder stretching of upper trapezius muscle, pectorals and levator scapule and isometric exercises of rotator cuff muscles performed in supine .( 10 sec hold and 10 to 15 reps)..
conventional treatmentOther
Conventional Treatment: heating pad for 15 minutes, TENS (Transcutaneous Electrical Nerve Stimulation) and after that shoulder stretching of upper trapezius muscle, pectorals and levator scapule and isometric exercises of rotator cuff muscles performed in supine .( 10 sec hold and 10 to 15 reps)..
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic stabilization exercises | Experimental | baseline physical therapy conventional treatment along Rhythmic stabilization exercises Receives: Other: Rhythmic stabilization exercises |
| Conventional treatment | Other | Baseline physical therapy conventional treatment Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair User's Shoulder Pain Index
The Wheelchair User's Shoulder Pain Index (WUSPI) was designed to measure shoulder pain in individuals who use wheelchairs. On the visual analog scale from ' 0' to '10 ' estimate level of pain with different activities
Measured: 6th Week
Secondary outcomes (1)
Shoulder rating Questionnaire
Shoulder rating questionnaire (SRQ) was designed to assess the severity of symptoms related to and the functional status of the shoulder. It includes domains of global assessment, pain, daily activities, recreational and athletic activities, work, satisfaction, and areas for improvement. Each domain is graded separately and is weighted to arrive at the total score
Measured: 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start30 Nov 2020
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Ikram, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967911
- Sponsor's protocol ID
- REC/Lhr/21/0205 Hira
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mason B, Warner M, Briley S, Goosey-Tolfrey V, Vegter R. Managing shoulder pain in manual wheelchair users: a scoping review of conservative treatment interventions. Clin Rehabil. 2020 Jun;34(6):741-753. doi: 10.1177/0269215520917437. Epub 2020 May 12.
PubMed 32397819El Essi K, El-Shafie JM, Al Hawamdah Z, Zaqout SI. Shoulder Pain among Rehabilitated Spinal Cord Injured Persons Using Manually Propelled Wheelchairs in the Gaza Strip: A Survey. Disabil CBR Incl Dev. 2012;23(2):53-71.
Soo Hoo J. Shoulder Pain and the Weight-bearing Shoulder in the Wheelchair Athlete. Sports Med Arthrosc Rev. 2019 Jun;27(2):42-47. doi: 10.1097/JSA.0000000000000241.
PubMed 31046007Jain NB, Higgins LD, Katz JN, Garshick E. Association of shoulder pain with the use of mobility devices in persons with chronic spinal cord injury. PM R. 2010 Oct;2(10):896-900. doi: 10.1016/j.pmrj.2010.05.004.
PubMed 20970758Samuelsson KA, Tropp H, Gerdle B. Shoulder pain and its consequences in paraplegic spinal cord-injured, wheelchair users. Spinal Cord. 2004 Jan;42(1):41-6. doi: 10.1038/sj.sc.3101490.
PubMed 14713943Walford SL, Requejo PS, Mulroy SJ, Neptune RR. Predictors of shoulder pain in manual wheelchair users. Clin Biomech (Bristol). 2019 May;65:1-12. doi: 10.1016/j.clinbiomech.2019.03.003. Epub 2019 Mar 6.
PubMed 30927682Giner-Pascual M, Alcanyis-Alberola M, Millan Gonzalez L, Aguilar-Rodriguez M, Querol F. Shoulder pain in cases of spinal injury: influence of the position of the wheelchair seat. Int J Rehabil Res. 2011 Dec;34(4):282-9. doi: 10.1097/MRR.0b013e32834a8fd9.
PubMed 21971486Çitaker S, Taşkiran H, Akdur H, Arabaci ÜmÖ, Ekici G. Comparison of the mobilization and proprioceptive neuromuscular facilitation methods in the treatment of shoulder impingement syndrome. Pain Clin. 2005 Jun;17(2):197-202.
Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.
PubMed 21292803
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propioceptive Neuromuscular Facilitation Technique on Shoulder Pain in Paraplegic Manual Wheel Chair Users After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04967911
- Acronym / sponsor ID
- REC/Lhr/21/0205 Hira
- Conditions
- Shoulder Impingement
- Keywords
- Spinal cord injury, wheelchair users, Shoulder pain, PNF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Jul 2021 (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.
This project was a Randomized control trial conducted to check the Effects of Proprioceptive Neuromuscular Facilitation on Shoulder Pain due to chronic impingement syndrome in paraplegic Manual Wheelchair users after Spinal Cord Injury so that we can have best treatment option for patients with shoulder pain due to manual wheelchair usage. duration was of 6months,convenient sampling was done, subject following eligibility criteria from Spine welfare trust center, Nawaz Sharif social security Hospital were randomly allocated in two groups via lottery method, Group A participants were given baseline treatment along with PNF exercises , Group B participants were given baseline treatment upto 6 weeks and 3 sessions per, post intervention assessment was done after 6 weeks, by self-generated questionnaire (WUSPI) wheel chair users shoulder pain index, (SRQ) Shoulder rating questionnaire and physical assessment by 2 special test was done, data was analyzed by using SPSS version 25.
Detailed description
In paraplegic manual wheelchair users Shoulder pain is most common problem after spinal cord injury. Due to wheelchair propulsion, weight relief task and other household activities repetitive load induced on upper limb and put substantial load in particular on shoulder.In spinal cord injured patients shoulder pain is because of over use of upper limb and shoulder during wheelchair related activities and personal care activities. less stability and slight muscle mass leads toward pain in their life at some point because of Muscular imbalance and later on shoulder secondary impingement syndrome. This study compared the rhythmic stabilization technique from PNF exercises with conventional treatment on experimental and control group to see the difference in reduction of pain and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythmic stabilization exercises | Experimental | Other: Rhythmic stabilization exercisesbaseline physical therapy conventional treatment along Rhythmic stabilization exercises |
| Conventional treatment | Other | Other: conventional treatmentBaseline physical therapy conventional treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-60 years old paraplegic manual wheel chair users after spinal cord injury.
- Those having level of injury from C7-T12
- Patients who are using wheelchair from more than one year.
- Pain perceived region of one or both Shoulder from last three months or more
- Pain without radicular symptoms radiating to whole upper limbs.
Key exclusion criteria (6 listed)
- Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, resting blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc.
- Any dislocation ,muscular tear and acute problem of shoulder.
- Presented with a diagnosis of cervical spinal stenosis, exhibited bilateral upper extremity symptoms
- Any recent surgery of the shoulder
- Individuals using other mobility devices with wheelchair.
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 |
|---|---|---|
| Rhythmic stabilization exercisesPNF techniques and Conventional Treatment: Experimental group received rhythmical Stabilization Technique on shoulder joint on all shoulder movements up to 1 minute in supine position For stability of joint ,re-establish dynamic rotator cuff stability and to enhance MS strength and decrease pain. Conventional Treatment: heating pad for 15 minutes, TENS (Transcutaneous Electrical Nerve Stimulation) and after that shoulder stretching of upper trapezius muscle, pectorals and levator scapule and isometric exercises of rotator cuff muscles performed in supine .( 10 sec hold and 10 to 15 reps).. | Other | Rhythmic stabilization exercises |
| conventional treatmentConventional Treatment: heating pad for 15 minutes, TENS (Transcutaneous Electrical Nerve Stimulation) and after that shoulder stretching of upper trapezius muscle, pectorals and levator scapule and isometric exercises of rotator cuff muscles performed in supine .( 10 sec hold and 10 to 15 reps).. | Other | Conventional treatment |
Primary outcome
Wheelchair User's Shoulder Pain Index
Time frame: 6th Week
The Wheelchair User's Shoulder Pain Index (WUSPI) was designed to measure shoulder pain in individuals who use wheelchairs. On the visual analog scale from ' 0' to '10 ' estimate level of pain with different activities
1 secondary outcome
Shoulder rating Questionnaire
Time frame: 6th Week
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 20 Jul 2021.
- Background: PubMed 32397819Mason B, Warner M, Briley S, Goosey-Tolfrey V, Vegter R. Managing shoulder pain in manual wheelchair users: a scoping review of conservative treatment interventions. Clin Rehabil. 2020 Jun;34(6):741-753. doi: 10.1177/0269215520917437. Epub 2020 May 12.
- BackgroundEl Essi K, El-Shafie JM, Al Hawamdah Z, Zaqout SI. Shoulder Pain among Rehabilitated Spinal Cord Injured Persons Using Manually Propelled Wheelchairs in the Gaza Strip: A Survey. Disabil CBR Incl Dev. 2012;23(2):53-71.
- Background: PubMed 31046007Soo Hoo J. Shoulder Pain and the Weight-bearing Shoulder in the Wheelchair Athlete. Sports Med Arthrosc Rev. 2019 Jun;27(2):42-47. doi: 10.1097/JSA.0000000000000241.
- Background: PubMed 20970758Jain NB, Higgins LD, Katz JN, Garshick E. Association of shoulder pain with the use of mobility devices in persons with chronic spinal cord injury. PM R. 2010 Oct;2(10):896-900. doi: 10.1016/j.pmrj.2010.05.004.
- Background: PubMed 14713943Samuelsson KA, Tropp H, Gerdle B. Shoulder pain and its consequences in paraplegic spinal cord-injured, wheelchair users. Spinal Cord. 2004 Jan;42(1):41-6. doi: 10.1038/sj.sc.3101490.
- Background: PubMed 30927682Walford SL, Requejo PS, Mulroy SJ, Neptune RR. Predictors of shoulder pain in manual wheelchair users. Clin Biomech (Bristol). 2019 May;65:1-12. doi: 10.1016/j.clinbiomech.2019.03.003. Epub 2019 Mar 6.
- Background: PubMed 21971486Giner-Pascual M, Alcanyis-Alberola M, Millan Gonzalez L, Aguilar-Rodriguez M, Querol F. Shoulder pain in cases of spinal injury: influence of the position of the wheelchair seat. Int J Rehabil Res. 2011 Dec;34(4):282-9. doi: 10.1097/MRR.0b013e32834a8fd9.
- BackgroundÇitaker S, Taşkiran H, Akdur H, Arabaci ÜmÖ, Ekici G. Comparison of the mobilization and proprioceptive neuromuscular facilitation methods in the treatment of shoulder impingement syndrome. Pain Clin. 2005 Jun;17(2):197-202.
- Background: PubMed 21292803Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.
- Individual participant dataSharing planned: No
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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.
Mehwish Ikram, 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 Rhythmic stabilization exercises and conventional treatment in people with Shoulder Impingement, 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 7 inclusion and 6 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 20 Jul 2021. 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?
Wheelchair User's Shoulder Pain Index (time frame: 6th Week). 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 NCT04967911, which also lists 9 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 2021.