Exercise Into Pain in Subacromial Shoulder Pain

NCT ID: NCT04553289

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-30

Study Completion Date

2022-12-15

Brief Summary

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The aim of the randomized clinical trial is to investigate if "exercising into pain" gives better results in term of clinical outcomes compared to a non-painful exercise program.

Detailed Description

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Exercise therapy is the first choice of treatment in the treatment of subacromial shoulder pain (SSP). Guidelines suggest exercise therapy for at least three months and research underlines the importance of progressive loaded exercise therapy at high dosage. However, it is not clear which is the best type of exercise and if pain should be provoked or avoided during exercise. Recent research found that painful exercises are beneficial in short term on pain and function in patients with different kinds of chronic musculoskeletal pain. The aim is to investigate if one painful exercise can give better and faster results in the management of SSP than non-painful program.

Conditions

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Shoulder Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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exercising into pain

The participants will train during 12 with progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, including 2 in closed kinetic chain exercises and 2 executed with the elastic band or with dumbbell/weight. One exercise will be performed with pain ranging between 4 and 7 on a NPRS (Numeric Pain Rating Scale) and the rest of the exercises will be performed with no/slight pain, ranging between 0 and 2 on NPRS. At week 9, patients will continue to exercise with pain between 0 and 2 in all exercises. 10/15 minutes of manual therapy (posterior capsular release) will be applied during the physiotherapy session.

Group Type EXPERIMENTAL

exercising into pain

Intervention Type OTHER

the intervention consists in 4 strength exercises: one will be performed into pain (ranging between 4 and 7 on NPRS scale) and the rest between 0 adn 2 on a NPRS scale

exercising with no/slight pain

The participants will train during 12 weeks with progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, including 2 in closed kinetic chain exercises and 2 executed with the elastic band or with dumbbell/weight. All the exercises will be performed with no/slight pain, ranging between 0 and 2 on NPRS. 10/15 minutes of manual therapy (posterior capsular release) will be applied during the physiotherapy session.

Group Type ACTIVE_COMPARATOR

exercising with no/slight pain

Intervention Type OTHER

the intervention consists in 4 strength exercises and all of them will be performed in no pain/slight pain (between 0 and 2 on NPRS scale)

Interventions

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exercising into pain

the intervention consists in 4 strength exercises: one will be performed into pain (ranging between 4 and 7 on NPRS scale) and the rest between 0 adn 2 on a NPRS scale

Intervention Type OTHER

exercising with no/slight pain

the intervention consists in 4 strength exercises and all of them will be performed in no pain/slight pain (between 0 and 2 on NPRS scale)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* shoulder pain for at least 3 months, elicited in the anterolateral shoulder region
* at least 3 out of 5 of the following tests positive: Neer test, Hawkins-Kennedy, Jobe, painful arc, external resistance test
* resting pain should be at 2/10 maximum on verbal numerical pain rating scale (NPRS)

Exclusion Criteria

* bilateral shoulder pain
* corticosteroid injections 6 weeks prior to the study
* pregnancy, inability to understand spoken or written Dutch
* clinical signs of full-thickness rotator cuff tears (positive external and internal rotation lag tests and drop arm test)
* evidence of adhesive capsulitis
* previous cervical, thoracic or shoulder surgery; recent fractures or dislocations on the painful shoulder
* primary complaint of spinal pain or signs of central nervous system involvement or signs of cervical nerve root involvement; reproduction of shoulder pain with cervical rotation or axial compression
* primary diagnosis of acromioclavicular pathology, shoulder instability
* a radiologically confirmed fracture or previous medical imaging confirming the presence of calcification larger than 5 mm
* presence of competing pathologies (inflammatory arthritis, neurological disorders, fibromyalgia, malignancy, psychiatric illness, osteoporosis, hemophilia, rheumatic polymyalgia)
* more than 4h of training in sport overhead shoulder activities per week
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaga

OTHER

Sponsor Role collaborator

Rotterdam University of Applied Sciences

OTHER

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Filip Struyf

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip Struyf, Professor

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

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Physiotherapy private practices

Antwerp, , Belgium

Site Status

Countries

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Belgium

References

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Cavaggion C, Navarro-Ledesma S, Juul-Kristensen B, Luque-Suarez A, Voogt L, Struyf F. The effect of painful exercise on ultrasonographic outcomes in rotator cuff-related shoulder pain: Secondary analysis of a randomized controlled trial. J Back Musculoskelet Rehabil. 2025 May 14:10538127251334430. doi: 10.1177/10538127251334430. Online ahead of print.

Reference Type DERIVED
PMID: 40368129 (View on PubMed)

Cavaggion C, Luque-Suarez A, Voogt L, Juul-Kristensen B, Wollants G, Beke L, Fransen E, Struyf F. Exercise into Pain in Chronic Rotator Cuff-Related Shoulder Pain: A Randomized Controlled Trial with 6-Month Follow-Up. Open Access J Sports Med. 2024 Nov 30;15:181-196. doi: 10.2147/OAJSM.S483272. eCollection 2024.

Reference Type DERIVED
PMID: 39635498 (View on PubMed)

Other Identifiers

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18/34/379 (RCT)

Identifier Type: -

Identifier Source: org_study_id

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