Shoulder PainPSTVSTPTNCT04859387
Effectiveness of Pragmatic Shoulder Technique VS Traditional Physical Therapy
A study testing set of pragmatic shoulder technique and traditional physical therapy in people with Shoulder Pain and Shoulder Impingement, run by Helping Hand Institute of Rehabilitation Sciences at 1 site in Pakistan.
Trial summary
Isolated and combined effectiveness of pragmatic protocols on shoulder range of motion had been investigated and found effective in healthy participants. To our knowledge, there was insufficient literature to support the comparison between pragmatic and traditional protocols in the treatment of shoulder pathologies. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement, Shoulder Injuries
- What is being tested?
- set of pragmatic shoulder technique and traditional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2020to 23 Sep 2020
- 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
- Functional movement score 1 and 2 or limitation in Range of motion of Abduction, internal rotation, external rotation, RUBB, and RDBN. All or only one of the limitations in comparison with the unaffected shoulder joint.
Who cannot join
- Patients with shoulder instability. Functional movement score 3 and 0. Individuals with recent fractures of fewer than 6 weeks duration. Cancerous Growth around the shoulder girdle. Breast cancer and undergoing chemotherapy and radiotherapy. RA arthritis patients. Long-term use of steroids and severe osteoporosis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Helping hand Institute of Rehabilitation Sciences Trust
Mansehra, KPK, 21300
About this study
Official title: Effectiveness of Pragmatic Shoulder Techniques in Comparison With Traditional Physical Therapy in Patients With Shoulder Pathologies
Isolated and combined effectiveness of pragmatic protocols on shoulder range of motion had been investigated and found effective in healthy participants. To our knowledge, there was insufficient literature to support the comparison between pragmatic and traditional protocols in the treatment of shoulder pathologies.
Read the detailed description
Different physical therapy treatments are being used for shoulder pathologies which include modalities (hot pack, TENS), ROM exercises, stretching, strengthening, soft tissue mobilization and set of pragmatic manual techniques.The set of pragmatic manual therapies are novel techniques (comprises of acromioclavicular mobilization, serratus anterior stretch, thoracic manipulation, RC facilitation, and PCS) and its isolated effectiveness on ROM in healthy subjects has been investigated and found effective. These studies recommended the use of a pragmatic protocol for the prevention and rehabilitation of shoulder injuries and pathologies (unpublished data).As per our knowledge there is insufficient literature to support the comparison of the effectiveness of a set of pragmatic protocols with traditional interventions. Our research is proposed to compare the efficacy of pragmatic interventions with that of traditional interventions in patients with shoulder pathology and their effect on the quality of life.
- Conditions
- Shoulder Pain, Shoulder Impingement, Shoulder Injuries, Frozen Shoulder, Shoulder Capsulitis
- Being tested
- set of pragmatic shoulder technique, traditional physical therapy
- Keywords
- pragmatic intervention,, shoulder pathologies,, shoulder pain,, shoulder range of motion, pragmatic shoulder intervention,
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Injuries, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
set of pragmatic shoulder techniqueOther
Group A received pragmatic intervention which includes Pectoralis major and minor stretch, AC joint mobilization, rotator cuff facilitation for subscapularis and infraspinatus, serratus anterior stretch, thoracic manipulation and posterior capsular stretch.
traditional physical therapyOther
Group B received traditional interventions which includes modalities such as TENS and hot pack, soft tissue mobilization, joint mobilization, stretching and strengthening etc. other than pragmatic intervention
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | set of pragmatic shoulder techniques Receives: Other: set of pragmatic shoulder technique |
| group B | Active comparator | traditional physical therapy Receives: Other: traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder Range of motion
will be measured in degrees by digital inclinometer
Measured: 5 days
functional movements
will be measured in centimeters by inchi tape
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start15 Apr 2020
- Primary completion30 Jul 2020
- Study completion23 Sep 2020
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 Shoulder PainStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- quasi-experimental
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helping Hand Institute of Rehabilitation Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keramat Ullah Keramat, Ph.D*, Principal investigator, HHIRS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859387
- Sponsor's protocol ID
- Rec-2020-F-002
- Acronym
- PSTVSTPT
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: as per the decision of helping hand research ethical committee (HHREC)
Publications
Keramat KU, Naveed Babur M. Pragmatic posterior capsular stretch and its effects on shoulder joint range of motion. BMJ Open Sport Exerc Med. 2020 Sep 9;6(1):e000805. doi: 10.1136/bmjsem-2020-000805. eCollection 2020.
PubMed 33062302Keramat KU, Babar MN. Serratus Anterior Stretch: A Novel Intervention and Its Effect on the Shoulder Range of Motion. J Sport Rehabil. 2021 Jan 8;30(5):824-827. doi: 10.1123/jsr.2020-0121.
PubMed 33418538
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pragmatic Shoulder Techniques in Comparison With Traditional Physical Therapy in Patients With Shoulder Pathologies
- ClinicalTrials.gov ID
- NCT04859387
- Acronym / sponsor ID
- PSTVSTPT / Rec-2020-F-002
- Conditions
- Shoulder Pain, Shoulder Impingement, Shoulder Injuries, Frozen Shoulder, Shoulder Capsulitis
- Keywords
- pragmatic intervention,, shoulder pathologies,, shoulder pain,, shoulder range of motion, pragmatic shoulder intervention,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Helping Hand Institute of Rehabilitation SciencesUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 26 Apr 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.
Isolated and combined effectiveness of pragmatic protocols on shoulder range of motion had been investigated and found effective in healthy participants. To our knowledge, there was insufficient literature to support the comparison between pragmatic and traditional protocols in the treatment of shoulder pathologies.
Detailed description
Different physical therapy treatments are being used for shoulder pathologies which include modalities (hot pack, TENS), ROM exercises, stretching, strengthening, soft tissue mobilization and set of pragmatic manual techniques.The set of pragmatic manual therapies are novel techniques (comprises of acromioclavicular mobilization, serratus anterior stretch, thoracic manipulation, RC facilitation, and PCS) and its isolated effectiveness on ROM in healthy subjects has been investigated and found effective. These studies recommended the use of a pragmatic protocol for the prevention and rehabilitation of shoulder injuries and pathologies (unpublished data).As per our knowledge there is insufficient literature to support the comparison of the effectiveness of a set of pragmatic protocols with traditional interventions. Our research is proposed to compare the efficacy of pragmatic interventions with that of traditional interventions in patients with shoulder pathology and their effect on the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: set of pragmatic shoulder techniqueset of pragmatic shoulder techniques |
| group B | Active comparator | Other: traditional physical therapytraditional physical therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Functional movement score 1 and 2 or limitation in Range of motion of Abduction, internal rotation, external rotation, RUBB, and RDBN. All or only one of the limitations in comparison with the unaffected shoulder joint.
Key exclusion criteria (1 listed)
- Patients with shoulder instability. Functional movement score 3 and 0. Individuals with recent fractures of fewer than 6 weeks duration. Cancerous Growth around the shoulder girdle. Breast cancer and undergoing chemotherapy and radiotherapy. RA arthritis patients. Long-term use of steroids and severe 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 |
|---|---|---|
| set of pragmatic shoulder techniqueGroup A received pragmatic intervention which includes Pectoralis major and minor stretch, AC joint mobilization, rotator cuff facilitation for subscapularis and infraspinatus, serratus anterior stretch, thoracic manipulation and posterior capsular stretch. | Other | group A |
| traditional physical therapyGroup B received traditional interventions which includes modalities such as TENS and hot pack, soft tissue mobilization, joint mobilization, stretching and strengthening etc. other than pragmatic intervention | Other | group B |
Primary outcome
shoulder Range of motion
Time frame: 5 days
will be measured in degrees by digital inclinometer
functional movements
Time frame: 5 days
will be measured in centimeters by inchi tape
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 2 Jun 2021.
- Background: PubMed 33062302Keramat KU, Naveed Babur M. Pragmatic posterior capsular stretch and its effects on shoulder joint range of motion. BMJ Open Sport Exerc Med. 2020 Sep 9;6(1):e000805. doi: 10.1136/bmjsem-2020-000805. eCollection 2020.
- Background: PubMed 33418538Keramat KU, Babar MN. Serratus Anterior Stretch: A Novel Intervention and Its Effect on the Shoulder Range of Motion. J Sport Rehabil. 2021 Jan 8;30(5):824-827. doi: 10.1123/jsr.2020-0121.
- Individual participant dataSharing planned: No. as per the decision of helping hand research ethical committee (HHREC)
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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.
Keramat Ullah Keramat, Ph.D* principal investigator
HHIRS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing set of pragmatic shoulder technique and traditional physical therapy in people with Shoulder Pain and Shoulder Impingement, run by Helping Hand Institute of Rehabilitation Sciences 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 1 inclusion and 1 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 2 Jun 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?
shoulder Range of motion (time frame: 5 days). 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?
On the ClinicalTrials.gov record for NCT04859387, 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 2 Jun 2021.