Shoulder Adhesive CapsulitisNCT04782349
Mulligan Mobilization With Laser for Shoulder Adhesive Capsulitis
A study testing mulligan mobilization with low level laser therapy and traditional physical therapy exercises, low level laser therapy and traditional physical therapy exercises and physical therapy exercises in people with Shoulder Adhesive Capsulitis, run by Cairo University at 1 site in Egypt.
Trial summary
Adhesive capsulitis (frozen shoulder) is a condition of uncertain etiology characterized by pain and progressive loss of both active and passive shoulder motion. Shoulder pain and stiffness are accompanied by disability. It is thought that the incidence is 3 to 5% in the general population. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Shoulder Adhesive Capsulitis
- What is being tested?
- mulligan mobilization with low level laser therapy and traditional physical therapy exercises, low level laser therapy and traditional physical therapy exercises and physical therapy exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 15 Aug 2022
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The participant selected for the study were patients (both male and female).
- Subjects diagnosed diagnosed by physicians with Magnetic Resonance Imaging (MRI).
- \& referred by an Orthopedician with stage 2 Adhesive Capsulitis.
- Age group of 40-60 years of old.
- painful condition of at least 3 months with 50% restriction in passive shoulder flexion, abduction and external rotation, in a sagittal plane compared with opposite side.
- The severity of pain on visual analogue scale was higher than three out of ten, pain aggravated by movements.
- patients were suffering from pain and limitation in the motion for more than 3 month.
Who cannot join
- Patients with any shoulder injury or trauma, surgical release of capsule.
- Previous manipulation done under anaesthesia of the affected shoulder in the preceding 4 weeks.
- Other conditions involving the shoulder (eg. rheumatoid arthritis, osteoarthritis, damage of the glenohumeral cartilage, osteoporosis, or malignancies in the shoulder region).
- Pain or disorders of the cervical spine, elbow, wrist, or hand.
- Presence of medical conditions such as cardiac disease, infections, coagulation disorder.
- patients having any intra articular injection, or physiotherapy treatment in the affected shoulder during the last three months.
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- patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and patients with tendon calcification, patients with cervical rib, rotator cuff tear patients.
- Patients have insulin-dependent diabetes mellitus.
- Bilateral Frozen Shoulder
- systemic inflammatory joint disease (such as rheumatoid arthritis or polymyalgia rheumatica).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additive Effect of Mulligan Mobilization With Low Level Laser Therapy for Treatment of Patients With Shoulder Adhesive Capsulitis: Double Blinded, Randomized Controlled Trial.
Adhesive capsulitis (frozen shoulder) is a condition of uncertain etiology characterized by pain and progressive loss of both active and passive shoulder motion.
Shoulder pain and stiffness are accompanied by disability. It is thought that the incidence is 3 to 5% in the general population. Laser therapy is widely used for treating different musculoskeletal diseases, because of its ability to reduce pain and improve the physical function. Also, MWM when used for shoulders with limited range of motion because of pain had shown improvement in range of motion and pressure pain threshold. Previous studies have investigated the efficacy of combining different manual technique with LLLT for treating pain in some body parts. However, up till now the combined effect of MWM with LLLT for treatment of patients with shoulder adhesive capsulitis have not been investigated.
So, the present randomized controlled study will be conducted to investigate the effect of adding mulligan mobilization with movement to low level laser therapy in treatment of patients with shoulder adhesive capsulitis.
- Conditions
- Shoulder Adhesive Capsulitis
- Being tested
- mulligan mobilization with low level laser therapy and traditional physical therapy exercises, low level laser therapy and traditional physical therapy exercises, physical therapy exercises
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mulligan mobilization with low level laser therapy and traditional physical therapy exercisesOther
for mulligan mobilization: for improving the limited range of motion of shoulder joint, the therapist will apply posterolateral mobilization for the shoulder joint. Three sets of painless glides of 10 repetitions will be applied with a rest interval of 30 s between each set.
For low level laser application: Laser specifications is as follows: 850 nm wave length and pulsed application with 8 W applied for 20 minutes. laser will be applied over painful points of the shoulder.
For traditional physical therapy exercises: the patients will receive the following exercise program: self stretching exercises for shoulder joint, pully exercises, back climbing exercises, finger ladder exercises, circumduction exercises and pendulum exercises
low level laser therapy and traditional physical therapy exercisesOther
patients in this group will receive low level laser and traditional physical exercises as described before for group (A)
physical therapy exercisesOther
The patients will receive traditional physical therapy exercises only as described before for group (A)
| Study group | Role | What they receive |
|---|---|---|
| high intensity laser group | Experimental | Not described Receives: Other: mulligan mobilization with low level laser therapy and traditional physical therapy exercises |
| low intensity laser group | Experimental | Not described Receives: Other: low level laser therapy and traditional physical therapy exercises |
| control group | Other | Not described Receives: Other: physical therapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured with Visual Analog Scale (VAS). The patient will be asked to mark the severity of pain on a 100-mm line with "no pain" on one end and "most unbearable pain" on the other end
Measured: change from base line at three weeks
Secondary outcomes (3)
pain pressure threshold
- The most sensitive point will be located over the anterior aspect of the shoulder by manual palpation and will be marked with a permanent marker so that the same point could be used for pre- and post-condition application measures. This process will be repeated three times with a 30-s rest period between each measurement.
Measured: change from baseline at three weeks
Shoulder range of motion (flexion, abduction, and external rotation)
A universal goniometer will be used to measure the ROM.
- patient in supine lying with shoulder neutral.
- Flexion ROM will be measured with the stationary arm of goniometer parallel to the trunk, and the moving arm parallel with the affected arm. Fulcrum will be placed in the point of lateral aspect of acromion process.
- For measurement of shoulder abduction, the fulcrum of the goniometer will be placed anterior to acromion process, stationary arm parallel to midline of sternum and movable arm will be placed at the midline of humerus. The patient is asked to abduct the arm as much as possible and the reading of the goniometer will be noted.
- For external rotation of the shoulder, patient is positioned in supine lying and arm abducted to 90 degree and elbow at 90 degree. Fulcrum of goniometry over olecranon and stationary arm perpendicular to floor, moving arm is aligned parallel to the ulna. The patient is asked to rotate externally as much as possible.
Measured: change from baseline at three weeks
Disability of Arm Shoulder Hand (DASH):
- The functional index designed to determine the symptoms and limitations that participant was experiencing while performing daily activities. This scale consists of 30 items in the form of activities of daily living with each item scoring from 0 to 4, where 0 is no difficulty in performing that activity and 4 is unable to do that activity. The DASH score is expressed as a percentage.
Measured: change from baseline at three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Dec 2021
- Primary completion25 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Shafiek Mustafa Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782349
- Sponsor's protocol ID
- Treatment of frozen shoulder
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lirio Romero C, Torres Lacomba M, Castilla Montoro Y, Prieto Merino D, Pacheco da Costa S, Velasco Marchante MJ, Bodes Pardo G. Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial. J Chiropr Med. 2015 Dec;14(4):249-58. doi: 10.1016/j.jcm.2015.03.001. Epub 2015 Nov 24.
PubMed 26793036Noten S, Meeus M, Stassijns G, Van Glabbeek F, Verborgt O, Struyf F. Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):815-25. doi: 10.1016/j.apmr.2015.07.025. Epub 2015 Aug 15.
PubMed 26284892Ip D, Fu NY. Two-year follow-up of low-level laser therapy for elderly with painful adhesive capsulitis of the shoulder. J Pain Res. 2015 May 25;8:247-52. doi: 10.2147/JPR.S84376. eCollection 2015.
PubMed 26045677
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effect of Mulligan Mobilization With Low Level Laser Therapy for Treatment of Patients With Shoulder Adhesive Capsulitis: Double Blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04782349
- Acronym / sponsor ID
- Treatment of frozen shoulder
- Conditions
- Shoulder Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 4 Mar 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.
Adhesive capsulitis (frozen shoulder) is a condition of uncertain etiology characterized by pain and progressive loss of both active and passive shoulder motion.
Shoulder pain and stiffness are accompanied by disability. It is thought that the incidence is 3 to 5% in the general population. Laser therapy is widely used for treating different musculoskeletal diseases, because of its ability to reduce pain and improve the physical function. Also, MWM when used for shoulders with limited range of motion because of pain had shown improvement in range of motion and pressure pain threshold. Previous studies have investigated the efficacy of combining different manual technique with LLLT for treating pain in some body parts. However, up till now the combined effect of MWM with LLLT for treatment of patients with shoulder adhesive capsulitis have not been investigated.
So, the present randomized controlled study will be conducted to investigate the effect of adding mulligan mobilization with movement to low level laser therapy in treatment of patients with shoulder adhesive capsulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high intensity laser group | Experimental | Other: mulligan mobilization with low level laser therapy and traditional physical therapy exercises |
| low intensity laser group | Experimental | Other: low level laser therapy and traditional physical therapy exercises |
| control group | Other | Other: physical therapy exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The participant selected for the study were patients (both male and female).
- Subjects diagnosed diagnosed by physicians with Magnetic Resonance Imaging (MRI).
- \& referred by an Orthopedician with stage 2 Adhesive Capsulitis.
- Age group of 40-60 years of old.
- painful condition of at least 3 months with 50% restriction in passive shoulder flexion, abduction and external rotation, in a sagittal plane compared with opposite side.
Key exclusion criteria (10 listed)
- Patients with any shoulder injury or trauma, surgical release of capsule.
- Previous manipulation done under anaesthesia of the affected shoulder in the preceding 4 weeks.
- Other conditions involving the shoulder (eg. rheumatoid arthritis, osteoarthritis, damage of the glenohumeral cartilage, osteoporosis, or malignancies in the shoulder region).
- Pain or disorders of the cervical spine, elbow, wrist, or hand.
- Presence of medical conditions such as cardiac disease, infections, coagulation disorder.
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 |
|---|---|---|
| mulligan mobilization with low level laser therapy and traditional physical therapy exercisesfor mulligan mobilization: for improving the limited range of motion of shoulder joint, the therapist will apply posterolateral mobilization for the shoulder joint. Three sets of painless glides of 10 repetitions will be applied with a rest interval of 30 s between each set. For low level laser application: Laser specifications is as follows: 850 nm wave length and pulsed application with 8 W applied for 20 minutes. laser will be applied over painful points of the shoulder. For traditional physical therapy exercises: the patients will receive the following exercise program: self stretching exercises for shoulder joint, pully exercises, back climbing exercises, finger ladder exercises, circumduction exercises and pendulum exercises | Other | high intensity laser group |
| low level laser therapy and traditional physical therapy exercisespatients in this group will receive low level laser and traditional physical exercises as described before for group (A) | Other | low intensity laser group |
| physical therapy exercisesThe patients will receive traditional physical therapy exercises only as described before for group (A) | Other | control group |
Primary outcome
Pain intensity
Time frame: change from base line at three weeks
Pain intensity will be measured with Visual Analog Scale (VAS). The patient will be asked to mark the severity of pain on a 100-mm line with "no pain" on one end and "most unbearable pain" on the other end
3 secondary outcomes
pain pressure threshold
Time frame: change from baseline at three weeks
Shoulder range of motion (flexion, abduction, and external rotation)
Time frame: change from baseline at three weeks
Disability of Arm Shoulder Hand (DASH):
Time frame: change from baseline at three weeks
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 25 Jan 2023.
- Background: PubMed 26793036Lirio Romero C, Torres Lacomba M, Castilla Montoro Y, Prieto Merino D, Pacheco da Costa S, Velasco Marchante MJ, Bodes Pardo G. Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial. J Chiropr Med. 2015 Dec;14(4):249-58. doi: 10.1016/j.jcm.2015.03.001. Epub 2015 Nov 24.
- Background: PubMed 26284892Noten S, Meeus M, Stassijns G, Van Glabbeek F, Verborgt O, Struyf F. Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):815-25. doi: 10.1016/j.apmr.2015.07.025. Epub 2015 Aug 15.
- Background: PubMed 26045677Ip D, Fu NY. Two-year follow-up of low-level laser therapy for elderly with painful adhesive capsulitis of the shoulder. J Pain Res. 2015 May 25;8:247-52. doi: 10.2147/JPR.S84376. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mulligan mobilization with low level laser therapy and traditional physical therapy exercises, low level laser therapy and traditional physical therapy exercises and physical therapy exercises in people with Shoulder Adhesive Capsulitis, run by Cairo University at 1 site in Egypt.
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 10 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 25 Jan 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 Egypt. 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?
Pain intensity (time frame: change from base line at three weeks). 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 NCT04782349, which also lists 3 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 25 Jan 2023.