A Pilot Randomized Trial of Pain Neuroscience Education in the Rehabilitation After Arthroscopic Rotator Cuff Repair

NCT04522934 | Completed

• 1 other identifier: Neuroscience Rotator Cuff
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effects of a 8-week pain neuroscience education programme compared to a biomedical education programme on the rehabilitation of patients who undergo arthroscopic rotator cuff repair. Outcome measures included pain intensity, patients' attitudes and beliefs about pain, disability and quality of life.

Conditions

Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (5)

• Change Pain intensity: visual analogue scale

  The visual analogue scales is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a point in a straight horizontal line of fixed length, usually 10 cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best). The Minimal Clinically Important Difference (MCID) in subjects with shoulder pain is 2.2 cm.

  From baseline to the end of intervention (8 weeks)

• Pain catastrophizing

  Pain catastrophic was assessed using the Patient Catastrophizing Scale (PCS), a 52-point self-administered instrument with MCID of 4.5 points.

  From baseline to the end of intervention (8 weeks)

• Kinesiophobia

  Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK-11), a 44-point self-administered instrument with MCID established at 6.0 points

  From baseline to the end of intervention (8 weeks)

• Disability

  The degree of disability was assessed with the QuickDASH questionnaire, a self-administered instrument which expresses the degree of disability as a percentage on a scale of 0-100%, with MCID of 8% in subjects with shoulder pain.

  From baseline to the end end of intervention (8 weeks)

• Health-related quality of life: 5-dimension EuroQol questionnaire

  The health-related quality of life was assessed with the 5-dimension EuroQol questionnaire, with MCID established on a scale of 0.03-0.52 in the population with musculoskeletal pain.

  From baseline to the end of intervention (8 weeks)

Study Arms (2)

Pain Neuroscience Education

EXPERIMENTAL

Patients received 24 sessions, in a 8-week period, of multimodal physiotherapy along with four sessions of pain neuroscience education.

Behavioral: Pain Neuroscience Education

Biomedical Education

ACTIVE COMPARATOR

Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy along with four sessions of biomedical education.

Behavioral: Biomedical Education

Interventions

Pain Neuroscience Education BEHAVIORAL

Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of pain neuroscience education. The latter was focused on the influence of psychosocial factors in the experience of pain, differences between acute and chronic pain and central-peripheral awareness.

Pain Neuroscience Education

Biomedical Education BEHAVIORAL

Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of biomedical education. The latter was focused on the anatomy and pathomechanics of the shoulder.

Biomedical Education

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• People aged 30 to 59 years with shoulder pain for more than three months, with torn rotator cuff repaired by arthroscopy.

You may not qualify if:

• Subjects unable to understand, read or speak Spanish, or participated in a programme for psychological management of chronic pain, or presented with generalised pain.

Sponsors & Collaborators

• Universidad Católica del Maule: lead

Study Sites (1)

Hospital de Temuco

Temuco, Región de la Araucanía, 4780000, Chile

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Felipe Ponce, BSc

  Universidad Santo Tomas, Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants were randomly assigned to groups by using an online random generator. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 21, 2020
• Study Start: February 26, 2018
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

CL (1)