Impingement SyndromeNCT04579003
Mobilization and Mobilization With Movement Effect on Sub Acromial Space in Impingement Syndrome.
A study testing Mobilization and Mobilization with movement in people with Impingement Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mobilization and mobilization with movement both treatment techniques are effective in impingement syndrome.The objective of our study is to compare the effects of shoulder mobilization and mobilization with movement on subacromial space in impingement syndrome. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Impingement Syndrome
- What is being tested?
- Mobilization and Mobilization with movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Dec 2019to 13 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Impingement Syndrome Screening using Neer Impingement Test, Hawkin Kennedy Test.
- Patients with impingement syndrome in acute phase.
Who cannot join
- Frozen Shoulder
- Thoracic Outlet Syndrome
- Cervical Radiculopathy
- Any Fracture or dislocation of shoulder girdle.
- Diabetic Patients.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Max Rehab & Physical Therapy Centre G-8 Markaz
Islamabad, Fedral, 46000
About this study
Official title: Effect of Shoulder Mobilization and Mobilization With Movement on Sub Acromial Space in Shoulder Impingement.
Mobilization and mobilization with movement both treatment techniques are effective in impingement syndrome.The objective of our study is to compare the effects of shoulder mobilization and mobilization with movement on subacromial space in impingement syndrome.
Read the detailed description
A study was conducted in 2016 to determine the effect of MWM in Impingement syndrome on sub acromial space, pain and disability. In this study,15 patients diagnosed with sub acromial impingement were selected and treated for six sessions. MWM posterolateral glide was the intervention selected. The results showed the p value of <0.00001 for pre and post treatment sessions of MWM in patients with Impingement syndrome. According to the results it was concluded that in terms of decreasing the pain and disability as well as increasing the acromiohumeral distance MWM is effective treatment for impingement syndrome.
An RCT was conducted in 2016 to find out the effect of posterolateral glide MWM on pain, strength of shoulder muscles and upward rotation of scapula. 31 patients were allocated to a group performing exercises actively and other group who received posterolateral glides MWM. The results suggested that MWM was effective intervention in decreasing pain on VAS and improving strength of external rotators.
A study was conducted in 2013 to compare the effects of supervised exercise with and without manual therapy for impingement syndrome.The results showed marked differences in reducing pain and increasing ROM and strength of rotator muscles in group that received supervised exercise with manual therapy. So it was concluded that manual therapy with exercise program is effective in decreasing pain and improving ROM than exercises alone in impingement syndrome.
A study was conducted to compare the effects of mobilization with movement and mobilization with therapeutic exercises in patients of subacromial impingement. The results are suggestive that shoulder mobilization and MWM with exercises result in more reduction of pain and improved AROM.
A RCT was conducted to compare the effectiveness of joint and soft tissue mobilization techniques and self-training program. The results of this study showed that patient who received manual therapy showed significant differences. So it was concluded that joint mobilization is effective intervention for patients with impingement syndrome.
Studies have been conducted in the past on effect of mobilization and mobilization with movement on shoulder impingement but they did not report their effect on sub acromial space in impingement syndrome using musculoskeletal ultrasound and the comparison of both techniques.
The purpose of this study is to find out the effects of mobilization and mobilization with movement on sub acromial space using musculoskeletal ultrasound in impingement syndrome and compare their outcomes.
- Conditions
- Impingement Syndrome
- Being tested
- Mobilization, Mobilization with movement
- Keywords
- Impingement syndrome, Mobilization, Mobilization with movement, Sub acromial space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationOther
Moist hot pack for 10 mins/1 set/ 6 consecutive days, Ultrasound for 5 mins/1 set/ 6 consecutive days, TENS on shoulder region for 10 mins/1 set/ 6 consecutive days, Shoulder mobilization posterolateral glide for 30 secs with 30 secs rest for 5 mins.
A total of 6 consecutive sessions were given each consisting of 30 mins.
Mobilization with movementOther
Moist hot pack for 10 mins/1 set/ 6 consecutive days, Ultrasound for 5 mins/1 set/ 6 consecutive days, TENS on shoulder region for 10 mins/1 set/ 6 consecutive days, Shoulder mobilization with movement (MWM) 10 repetitions with 30 secs rest for 5 mins.
A total of 6 consecutive sessions were given each consisting of 30 mins.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization | Experimental | Mobilization, heat application, ultrasound, TENS Receives: Other: Mobilization |
| Mobilization with movement | Active comparator | Mobilization with movement, heat application, ultrasound, TENS Receives: Other: Mobilization with movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub acromial Space
Changes from baseline, for measuring sub acromial space, patients were seated with arm resting at the side with fully extended elbow, trunk in neutral position and ultrasound images were taken using linear transducer probe. The ultrasound transducer was positioned on the shoulder over the acromion and humeral head. AHD was measured using onscreen calipers by finding superior aspect of head of humerus and inferior aspect of acromion (between apex of greater tubercle of humerus and inferior edge of acromial process). Three readings were taken which then averaged for a single reading.
Measured: 6th day
Secondary outcomes (3)
Supraspinatus Tendon Thickness
Changes from baseline, Transducer was placed on shoulder over subacromial space with the notch diagonally facing down towards the belly button, measured in transverse view lateral to the biceps tendon of long head.
Measured: 6th day
Numeric Pain Rating Scale
Changes from baseline, Numeric pain rating scale is a scale from 0 to 10. 0 indicating no pain and 10 indicating worse pain.
Measured: 6th day
Range of motion ( ROM)
Changes from baseline, shoulder ROM were taken using goniometer
Measured: 6th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start6 Dec 2019
- Primary completion10 Sep 2020
- Study completion13 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Impingement SyndromeStudies 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
- Both groups were treated simultaneously with their specified treatment techniques within given duration.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asghar Khan, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579003
- Sponsor's protocol ID
- REC/00692 Aneela Ghafoor
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ajit D, Shika S. Effects of Mobilization with Movement (MWM) in Shoulder Impingement Syndrome Patients on Acromiohumeral Distance using Ultrasonography. Journal of Exercise Science & Physiotherapy. 2016;12(2).
Neelapala YR, Reddy YRS, Danait R. Effect of mulligan's posterolateral glide on shoulder rotator strength, scapular upward rotation in shoulder pain subjects-a randomized controlled trial. Journal of Musculoskeletal Research. 2016;19(03):1650014.
Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthop Sports Phys Ther. 2000 Mar;30(3):126-37. doi: 10.2519/jospt.2000.30.3.126.
PubMed 10721508Kachingwe AF, Phillips B, Sletten E, Plunkett SW. Comparison of manual therapy techniques with therapeutic exercise in the treatment of shoulder impingement: a randomized controlled pilot clinical trial. J Man Manip Ther. 2008;16(4):238-47. doi: 10.1179/106698108790818314.
PubMed 19771196
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shoulder Mobilization and Mobilization With Movement on Sub Acromial Space in Shoulder Impingement.
- ClinicalTrials.gov ID
- NCT04579003
- Acronym / sponsor ID
- REC/00692 Aneela Ghafoor
- Conditions
- Impingement Syndrome
- Keywords
- Impingement syndrome, Mobilization, Mobilization with movement, Sub acromial space
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 13 Sep 2020 (actual)
- First posted
- 8 Oct 2020 (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.
Mobilization and mobilization with movement both treatment techniques are effective in impingement syndrome.The objective of our study is to compare the effects of shoulder mobilization and mobilization with movement on subacromial space in impingement syndrome.
Detailed description
A study was conducted in 2016 to determine the effect of MWM in Impingement syndrome on sub acromial space, pain and disability. In this study,15 patients diagnosed with sub acromial impingement were selected and treated for six sessions. MWM posterolateral glide was the intervention selected. The results showed the p value of <0.00001 for pre and post treatment sessions of MWM in patients with Impingement syndrome. According to the results it was concluded that in terms of decreasing the pain and disability as well as increasing the acromiohumeral distance MWM is effective treatment for impingement syndrome.
An RCT was conducted in 2016 to find out the effect of posterolateral glide MWM on pain, strength of shoulder muscles and upward rotation of scapula. 31 patients were allocated to a group performing exercises actively and other group who received posterolateral glides MWM. The results suggested that MWM was effective intervention in decreasing pain on VAS and improving strength of external rotators.
A study was conducted in 2013 to compare the effects of supervised exercise with and without manual therapy for impingement syndrome.The results showed marked differences in reducing pain and increasing ROM and strength of rotator muscles in group that received supervised exercise with manual therapy. So it was concluded that manual therapy with exercise program is effective in decreasing pain and improving ROM than exercises alone in impingement syndrome.
A study was conducted to compare the effects of mobilization with movement and mobilization with therapeutic exercises in patients of subacromial impingement. The results are suggestive that shoulder mobilization and MWM with exercises result in more reduction of pain and improved AROM.
A RCT was conducted to compare the effectiveness of joint and soft tissue mobilization techniques and self-training program. The results of this study showed that patient who received manual therapy showed significant differences. So it was concluded that joint mobilization is effective intervention for patients with impingement syndrome.
Studies have been conducted in the past on effect of mobilization and mobilization with movement on shoulder impingement but they did not report their effect on sub acromial space in impingement syndrome using musculoskeletal ultrasound and the comparison of both techniques.
The purpose of this study is to find out the effects of mobilization and mobilization with movement on sub acromial space using musculoskeletal ultrasound in impingement syndrome and compare their outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both groups were treated simultaneously with their specified treatment techniques within given duration.
| Arm | Type | Receives |
|---|---|---|
| Mobilization | Experimental | Other: MobilizationMobilization, heat application, ultrasound, TENS |
| Mobilization with movement | Active comparator | Other: Mobilization with movementMobilization with movement, heat application, ultrasound, TENS |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Impingement Syndrome Screening using Neer Impingement Test, Hawkin Kennedy Test.
- Patients with impingement syndrome in acute phase.
Key exclusion criteria (5 listed)
- Frozen Shoulder
- Thoracic Outlet Syndrome
- Cervical Radiculopathy
- Any Fracture or dislocation of shoulder girdle.
- Diabetic Patients.
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 |
|---|---|---|
| MobilizationMoist hot pack for 10 mins/1 set/ 6 consecutive days, Ultrasound for 5 mins/1 set/ 6 consecutive days, TENS on shoulder region for 10 mins/1 set/ 6 consecutive days, Shoulder mobilization posterolateral glide for 30 secs with 30 secs rest for 5 mins. A total of 6 consecutive sessions were given each consisting of 30 mins. | Other | Mobilization |
| Mobilization with movementMoist hot pack for 10 mins/1 set/ 6 consecutive days, Ultrasound for 5 mins/1 set/ 6 consecutive days, TENS on shoulder region for 10 mins/1 set/ 6 consecutive days, Shoulder mobilization with movement (MWM) 10 repetitions with 30 secs rest for 5 mins. A total of 6 consecutive sessions were given each consisting of 30 mins. | Other | Mobilization with movement |
Primary outcome
Sub acromial Space
Time frame: 6th day
Changes from baseline, for measuring sub acromial space, patients were seated with arm resting at the side with fully extended elbow, trunk in neutral position and ultrasound images were taken using linear transducer probe. The ultrasound transducer was positioned on the shoulder over the acromion and humeral head. AHD was measured using onscreen calipers by finding superior aspect of head of humerus and inferior aspect of acromion (between apex of greater tubercle of humerus and inferior edge of acromial process). Three readings were taken which then averaged for a single reading.
3 secondary outcomes
Supraspinatus Tendon Thickness
Time frame: 6th day
Numeric Pain Rating Scale
Time frame: 6th day
Range of motion ( ROM)
Time frame: 6th day
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 8 Oct 2020.
- BackgroundAjit D, Shika S. Effects of Mobilization with Movement (MWM) in Shoulder Impingement Syndrome Patients on Acromiohumeral Distance using Ultrasonography. Journal of Exercise Science & Physiotherapy. 2016;12(2).
- BackgroundNeelapala YR, Reddy YRS, Danait R. Effect of mulligan's posterolateral glide on shoulder rotator strength, scapular upward rotation in shoulder pain subjects-a randomized controlled trial. Journal of Musculoskeletal Research. 2016;19(03):1650014.
- Background: PubMed 10721508Bang MD, Deyle GD. Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome. J Orthop Sports Phys Ther. 2000 Mar;30(3):126-37. doi: 10.2519/jospt.2000.30.3.126.
- Background: PubMed 19771196Kachingwe AF, Phillips B, Sletten E, Plunkett SW. Comparison of manual therapy techniques with therapeutic exercise in the treatment of shoulder impingement: a randomized controlled pilot clinical trial. J Man Manip Ther. 2008;16(4):238-47. doi: 10.1179/106698108790818314.
- 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.
Asghar Khan, 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 Mobilization and Mobilization with movement in people with 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 2 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: finished, as of the sponsor's last update on 8 Oct 2020. 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?
Sub acromial Space (time frame: 6th day). 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 NCT04579003, which also lists 4 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 8 Oct 2020.