Exercise Into Pain in Subacromial Shoulder Pain

NCT04553289 | Completed

• 1 other identifier: 18/34/379 (RCT)
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Impingement Syndrome

Keywords

shoulder pain; subacromial impingement syndrome; exercise therapy

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI)

  There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.

  Change from baseline to 12 weeks

Secondary Outcomes (25)

• Shoulder Pain and Disability Index (SPADI)

  Change from baseline to 6 months

• Visual Analogue Scale (VAS)

  Change from baseline to 12 weeks

• Visual Analogue Scale (VAS)

  Change from baseline to 6 months

• Health-Related Quality of Life

  Change from baseline to 12 weeks

• Health-Related Quality of Life

  Change from baseline to 6 months

Other Outcomes (2)

• Global perceived effect (GPE)

  12 weeks

• Adherence

  12 weeks

Study Arms (2)

exercising into pain

EXPERIMENTAL

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.

Other: exercising into pain

exercising with no/slight pain

ACTIVE COMPARATOR

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.

Other: exercising with no/slight pain

Interventions

exercising into pain 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 into pain

exercising with no/slight pain 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)

exercising with no/slight pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University of Malaga: collaborator
• Rotterdam University of Applied Sciences: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Physiotherapy private practices

Antwerp, Belgium

Location

Related Publications (2)

• 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 Nov;38(6):1379-1388. doi: 10.1177/10538127251334430. Epub 2025 May 14.

  PMID: 40368129 DERIVED

• 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.

  PMID: 39635498 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Struyf, Professor

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 17, 2020
• Study Start: August 30, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

BE (1)