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Thoracic Outlet SyndromeNCT05917756

Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome

A study testing Mobilization with Movement (MWM) and Standardized Rehabilitation in people with Thoracic Outlet Syndrome, run by Ahram Canadian University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate whether adding Mobilization With Movement (MWM) to a standardized rehabilitation program improves arm, shoulder, and hand function in adults with chronic neurogenic thoracic outlet syndrome (nTOS), compared with a sham manual procedure added to the same rehabilitation program. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Thoracic Outlet Syndrome
What is being tested?
Mobilization with Movement (MWM) and Standardized Rehabilitation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteEgypt
Study dates
1 Jul 2023to 12 Sep 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-65 years.
  • Symptoms consistent with neurogenic thoracic outlet syndrome (nTOS) for at least 3 months.
  • Diagnosis of nTOS confirmed by a physician experienced in thoracic outlet disorders using prespecified consensus-based clinical criteria, including compatible local thoracic outlet findings, peripheral upper-extremity symptoms suggesting brachial plexus irritation, and the absence of another diagnosis that better explains the presentation.
  • Symptoms consistent with nTOS that are reproduced or aggravated by relevant upper-extremity positions or sustained or repetitive activities, where applicable.
  • Ability to understand study procedures, provide written informed consent, and participate in the rehabilitation program and outcome assessments.

Who cannot join

  • Previous surgery for thoracic outlet syndrome.
  • Clinical evidence of arterial or venous thoracic outlet syndrome.
  • Acute or progressive vascular symptoms requiring medical or surgical evaluation.
  • Significant intrinsic hand-muscle atrophy or progressive objective motor weakness requiring specialist surgical assessment.
  • Cervical radiculopathy or myelopathy judged to be the principal cause of the participant's symptoms.
  • Clinically significant peripheral entrapment neuropathy, major shoulder pathology, brachial plexopathy, or another neurological or musculoskeletal condition judged to be the principal cause of upper-extremity symptoms.
Show all 9Show fewer
  • Previous major cervical or shoulder surgery likely to substantially affect upper-quarter biomechanics or outcome assessment.
  • Contraindications to manual therapy or therapeutic exercise.
  • Concurrent structured physiotherapy or manual therapy specifically directed at nTOS during the 8-week intervention period.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Outpatient clinic of faculty of physical therapy, Ahram Canadian University

    Al Ḩayy Ath Thāmin, Giza Governorate, 3221405

Other trials in Egypt

About this study

Official title: The Impact of Mobilization With Movement on Pain, Function, and Quality of Life in Patients With Thoracic Outlet Syndrome: A Randomized Controlled Trial

This study will investigate whether adding Mobilization With Movement (MWM) to a standardized rehabilitation program improves arm, shoulder, and hand function in adults with chronic neurogenic thoracic outlet syndrome (nTOS), compared with a sham manual procedure added to the same rehabilitation program.

A total of 120 participants aged 18-65 years will be randomly assigned to two equally sized groups. One group will receive MWM plus standardized rehabilitation, and the other will receive sham MWM plus the same rehabilitation program. The sham procedure will reproduce therapist contact, positioning, treatment time, and attention without the specific manual technique used in active MWM. Both groups will receive 16 supervised sessions over 8 weeks, with two 45-minute sessions per week, and the same home-exercise program.

Read more

The main outcome will be upper-extremity disability measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks. Additional outcomes will include pain intensity, disability at other assessment times, health-related quality of life, patient-perceived improvement, cervical range of motion, and adverse events. Scheduled assessments will take place before treatment and at 4, 8, and 12 weeks after randomization, with patient-perceived change assessed at Weeks 8 and 12.

Participants and outcome assessors will be masked to active versus sham manual treatment. The study hypothesis is that MWM added to standardized rehabilitation will produce greater improvement in upper-extremity disability than sham MWM added to the same rehabilitation program.

Being tested
Mobilization with Movement (MWM), Standardized Rehabilitation, Sham Mobilization With Movement
Medical subject headings
Thoracic Outlet Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobilization with Movement (MWM)Other

    Mulligan-concept Mobilization With Movement (MWM) will be applied to the first-rib, cervical, and upper-thoracic regions according to clinical indications. The treating physiotherapist will identify a comparable sign related to the participant's symptoms or functional limitation. A sustained accessory glide will be combined with an active movement. The selected technique must be pain-free during application and should produce an immediate improvement in the comparable sign. Up to three sets of 6-10 repetitions will be performed for the selected movement. Treatment parameters and immediate responses will be documented at each session. The MWM component will last approximately 10-15 minutes per session, twice weekly for 8 weeks (16 sessions).

  • Standardized RehabilitationOther

    Both study groups will receive an identical standardized, progression-based rehabilitation program consisting of education and activity modification, postural correction, scapular stabilization and motor control, progressive strengthening of the scapular and shoulder-girdle muscles, pectoral and scalene stretching when indicated, thoracic mobility exercises, and neural-mobility exercises according to symptom irritability. The supervised rehabilitation component will last approximately 30-35 minutes per session, twice weekly for 8 weeks (16 sessions). Participants in both groups will also receive the same standardized home-exercise program. Exercise dosage, progression criteria, and symptom-based modifications will follow the same predefined protocol in both groups.

  • Sham Mobilization With MovementOther

    Sham MWM will reproduce the active MWM procedure while omitting its defining sustained accessory glide. In a supported, symptom-tolerable position, the therapist will use only light, non-directional skin contact over the selected cervical or upper-thoracic area; for first-rib-targeted sessions, contact will be on the adjacent upper trapezius/shoulder surface, avoiding pressure in the supraclavicular fossa. Participants will perform the same prespecified comfortable active movement as in active MWM, for up to three sets of 6-10 repetitions, with 60-second rests. No directed joint force, first-rib depression, sustained glide, traction, thrust, tissue massage, neural tensioning, or end-range overpressure will be applied. The sham component will last approximately 10-15 minutes per session, twice weekly for 8 weeks.

Study groups in NCT05917756
Study groupRoleWhat they receive
Group A: MWM Plus Standardized RehabilitationExperimentalParticipants in the experimental group will receive Mulligan-concept Mobilization With Movement (MWM) targeting the first rib, cervical spine, and upper thoracic spine, according to clinical indications, combined with a standardized rehabilitation and home-exercise program. Treatment will be delivered by a qualified physiotherapist over 8 weeks, with two supervised sessions per week (16 sessions in total), each lasting approximately 45 minutes. The MWM component will occupy approximately 10-15 minutes, followed by 30-35 minutes of standardized rehabilitation, including postural correction, scapular control, strengthening, stretching, thoracic mobility, and neural-mobility exercises as clinically indicated.
Receives: Other: Mobilization with Movement (MWM); Other: Standardized Rehabilitation
Group B: Sham MWM Plus Standardized RehabilitationSham comparatorParticipants in the control group will receive sham Mobilization With Movement (MWM) combined with the same standardized rehabilitation and home-exercise program provided to the experimental group. The sham procedure will reproduce therapist contact, positioning, treatment duration, and attention without applying the specific sustained accessory glide combined with movement that characterizes active MWM. Treatment will be delivered over 8 weeks, with two supervised sessions per week (16 sessions in total), each lasting approximately 45 minutes. The sham component will occupy approximately 10-15 minutes, followed by 30-35 minutes of standardized rehabilitation. Exercise selection, dosage, and progression criteria will be identical in both groups.
Receives: Other: Standardized Rehabilitation; Other: Sham Mobilization With Movement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disabilities of the Arm, Shoulder and Hand (DASH) Score at 8 Weeks

    Upper-extremity disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Total scores range from 0 to 100, with higher scores indicating greater disability. The primary outcome will be the DASH score at 8 weeks after randomization. The primary treatment effect will be estimated as the adjusted between-group mean difference in Week-8 DASH scores using analysis of covariance (ANCOVA), with treatment group as the main factor and baseline DASH score as a covariate. Lower scores indicate better functional status.

    Measured: Baseline and 8 weeks after randomization

Secondary outcomes (6)
  1. Pain Intensity Measured Using the Numeric Pain Rating Scale (NPRS)

    Average neurogenic thoracic outlet syndrome-related upper-extremity pain during usual arm activities over the preceding 7 days will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Pain will be evaluated at baseline and at Weeks 4, 8, and 12 after randomization. The Week-8 NPRS score is the prespecified key secondary pain endpoint.

    Measured: Baseline and 4, 8, and 12 weeks after randomization; Week 8 is the key secondary pain endpoint.

  2. Disabilities of the Arm, Shoulder and Hand (DASH) Scores at 4 and 12 Weeks

    Upper-extremity disability will also be assessed using the 30-item DASH questionnaire at Weeks 4 and 12 after randomization. Scores range from 0 (no disability) to 100 (most severe disability), with lower scores indicating better function. Week-4 scores will characterize the early treatment response, and Week-12 scores will assess the persistence of any treatment effect following completion of the 8-week supervised intervention. Week 12 is the prespecified key secondary disability endpoint.

    Measured: Baseline and 4 and 12 weeks after randomization; Week 12 is the key secondary disability endpoint.

  3. Changes in Quality of Life

    Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire

    Measured: Baseline and 4, 8, and 12 weeks after randomization; Week-12 PCS is the key secondary quality-of-life endpoint.

  4. Patient Global Impression of Change (PGIC)

    Participants will rate their perceived overall change in neurogenic thoracic outlet syndrome-related symptoms and functioning since baseline using the 7-point Patient Global Impression of Change (PGIC) scale. Response options range from 1 (very much improved) to 7 (very much worse), with 4 indicating no change. Lower scores indicate greater perceived improvement. PGIC will be assessed at Weeks 8 and 12 after randomization.

    Measured: 8 and 12 weeks after randomization.

  5. Number of Participants Experiencing Adverse Events

    The number of participants experiencing at least one adverse event will be recorded for each randomized group. Events of interest include exacerbation of neurogenic thoracic outlet syndrome symptoms, increased pain or paresthesia, dizziness, headache, and new or worsened neurological or vascular symptoms. Serious adverse events will be documented separately. Adverse events will be monitored throughout treatment and follow-up, with event type, severity, timing, and relationship to the intervention recorded.

    Measured: From the first supervised treatment session through 12 weeks after randomization.

  6. Cervical Range of Motion

    Active cervical range of motion will be measured in degrees using a goniometer according to a standardized assessment procedure and consistent participant positioning. This exploratory physical measure will be used to support interpretation of changes in cervical mobility and will not serve as a primary or confirmatory endpoint.

    Measured: Baseline and 4, 8, and 12 weeks after randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start1 Jul 2023
  3. Primary completion25 Aug 2026
  4. Study completion12 Sep 2026

Resources

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
This study is a two-arm, parallel-group, randomized, sham-controlled superiority trial with an equal allocation ratio (1:1). A total of 120 participants with chronic neurogenic thoracic outlet syndrome will be randomly assigned to two groups (60 participants per group). The experimental group will receive Mobilization With Movement (MWM) combined with standardized rehabilitation, while the control group will receive sham MWM combined with the same standardized rehabilitation program. Both groups will receive 16 supervised treatment sessions over 8 weeks, with two sessions per week, and an identical home-exercise program. Outcomes will be assessed at baseline and at 4, 8, and 12 weeks after randomization.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05917756
Sponsor's protocol ID
012/0333666
Status last verified
Oct 2026
First submitted
15 Jun 2023
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mobilization with Movement (MWM) and Standardized Rehabilitation in people with Thoracic Outlet Syndrome, run by Ahram Canadian 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 5 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: finished, as of the sponsor's last update on 15 Oct 2026. 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. Some participants in this study may receive a placebo. 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?

Disabilities of the Arm, Shoulder and Hand (DASH) Score at 8 Weeks (time frame: Baseline and 8 weeks after randomization). 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 15 Oct 2026.

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