NCT06953895

Brief Summary

The aim of present study was to evaluate the immediate effect of Mulligan's mobilization with movement on shoulder girdle' pain, range of motion (ROM) and muscle activity, in subjects with shoulder impingement syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

April 24, 2025

Last Update Submit

April 24, 2025

Conditions

Keywords

Subacromial impingement syndromeMobilization with movementPressure pain thresholdSurface electromyography

Outcome Measures

Primary Outcomes (4)

  • Pain intensity

    The participant was asked to rate the pain intensity in Neer impingement signal and Hawkins-Kennedy impingement test, using a 100 mm visual analogue scale.

    baseline

  • Pain Pressure Threshold on the lateral aspect of shoulder

    Pressure algometry was performed to assess PPT on the lateral aspect of shoulder. A hand-held electronic pressure algometer Force One FDIX (Wagner Instruments, Greenwich CT, United States of America) with a 1 cm2 rubber-tipped probe area was applied perpendicular to the skin at a rate of 1 kg per second. The PPT was measured over the most sensitive point to manual palpation of the lateral aspect of shoulder. This region was marked with a permanent marker so that the same point could be used pre- and post-intervention. The researcher instructed the participant to say "ouch" as soon as sensation changed from feeling pressure to feeling pain. Three trials were performed, with a resting time of 30 seconds and a subsequent analysis of its average.

    baseline

  • Shoulder ROM

    Photogrammetry was performed to assess ROM of shoulder scaption until onset of pain. The ROM was recorded by photography, using a digital camera (30 frames/ second) placed in a perpendicular position to the plane of motion, at a distance of 3 meters from a flat surface. The photography was subsequently analyzed by a postural analysis software (SAPo version 0.69, open source software). To ensure consistent reference points, spherical markers were placed on the skin: one over the acromion and the last over the lateral epicondyle. The participant was asked to raise the arm until feeling pain, with elbow fully extended and thumb pointed up along a flat vertical surface positioned 30º anterior to the frontal plane.

    baseline

  • Shoulder muscle activity

    Surface electromyography (sEMG) was performed to assess the muscle activity of trapezius (upper, middle and lower) and SA, during concentric and eccentric phases of shoulder scaption. The muscle activity was recorded by BioPlux research device (Plux wireless biosignals S.A., Arruda dos Vinhos, Portugal) with 12-bit analog channels and a sampling frequency of 1000 Hz, using double differential electrode leads. To perform sEMG, the participant's hair was shaved, an abrasive cream was used to remove dead cells from the skin's surface, and the skin was cleaned with isopropyl alcohol (70%) to remove oil and remaining dead cells. An electrode impedance checker (Noraxon Corporate, Scottsdale AZ, United States of America) was used to ensure that impedance levels were less than 5 KΩ, which was considered to signify the satisfactory acquisition of the sEMG signal.

    baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

The Mulligan's MWM group received mobilization with movement in the glenohumeral joint, as described by Mulligan. The participant was seated, and the physiotherapist was placed on the opposite side to the affected shoulder with the thenar eminence of one hand over the anterior aspect of the humeral head, and the other hand over the spine of the scapula posteriorly of the affected shoulder. The hand over the humeral head performed a posterolateral glide, while the other hand stabilized the scapula. This maneuver was sustained while the participant asked to raise the arm in scapular plan (as explained above) without pain. The physiotherapist previously determined the amount of posterolateral pressure which was the best to abolish the pain during shoulder scaption for each participant.

Procedure: Mulligan's Mobilization With Movement

Placebo Group

PLACEBO COMPARATOR

In the Placebo group, no effective intervention was performed, the participant was asked to raise the affected arm in scapular plane without pain, while the physiotherapist placed their hands-on shoulder, with the same manual contacts described in Mulligan's MWM group, but without performing any pressure.

Procedure: Active Mobilization

Interventions

The Mulligan's MWM group received mobilization with movement in the glenohumeral joint, as described by Mulligan. The participant was seated, and the physiotherapist was placed on the opposite side to the affected shoulder with the thenar eminence of one hand over the anterior aspect of the humeral head, and the other hand over the spine of the scapula posteriorly of the affected shoulder. The hand over the humeral head performed a posterolateral glide, while the other hand stabilized the scapula. This maneuver was sustained while the participant asked to raise the arm in scapular plan (as explained above) without pain. The physiotherapist previously determined the amount of posterolateral pressure which was the best to abolish the pain during shoulder scaption for each participant. The participants performed three sets of 10 trials with a resting time of 30 seconds between each set. After intervention was allowed a resting time of three minutes.

Also known as: MWM
Intervention group

In the Placebo group, no effective intervention was performed, the participant was asked to raise the affected arm in scapular plane without pain, while the physiotherapist placed their hands-on shoulder, with the same manual contacts described in Mulligan's MWM group, but without performing any pressure. The participants performed three sets of 10 trials with a resting time of 30 seconds between each set. After intervention was allowed a resting time of three minutes.

Placebo Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants had superolateral shoulder pain and two out of four specified objective signs and symptoms:
  • positive Neer test;
  • positive Hawkins-Kennedy test;
  • painful limitation of active arm elevation (flexion, abduction, scaption);
  • pain or limitation with functional movement patterns of hand behind back or hand behind head.

You may not qualify if:

  • physician diagnosis of adhesive capsulitis;
  • grade III rotator cuff tear;
  • calcific tendinosis confirmed by radiology;
  • systemic or neurological disorder;
  • cervical radiculopathy; a history of shoulder surgery;
  • corticosteroid injection within the past month;
  • subjects who had received physical therapy intervention for their shoulder within the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E2S | P.PORTO - Escola Superior de Saúde do Politécnico do Porto

Porto, Porto District, 4200-072, Portugal

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Movement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

January 1, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations