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Clinical Trials/NCT04522934
NCT04522934
Completed
Not Applicable

A Pilot Randomized, Controlled Trial of the Effectiveness of Pain Neuroscience Education on Pain Intensity, Patients' Attitudes and Beliefs About Pain, Disability and Quality of Life After Arthroscopic Rotator Cuff Repair

Universidad Católica del Maule1 site in 1 country29 target enrollmentFebruary 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Injuries
Sponsor
Universidad Católica del Maule
Enrollment
29
Locations
1
Primary Endpoint
Kinesiophobia
Status
Completed
Last Updated
5 years ago

Overview

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.

Detailed Description

This was a single-blinded, randomized parallel study. Twenty- nine patients who undergo arthroscopic rotator cuff repair took part in a multimodal physiotherapy programme and were allocated to two groups. Patients in the experimental group - PNE (n= 16) received multimodal physiotherapy along with pain neuroscience education, and the control group- PME (n=13) received multimodal physiotherapy along with biomedical education. The multimodal treatment included 1-hour sessions 3 times per week for 8 weeks (24 sessions). In addition, the education component (PNE, PME) consisted of 4 education sessions of 30 minutes duration, on a one-to-one basis, once per week at the start of the programme. Physiotherapists involved in the delivery of the interventions were previously trained on both, the theoretical and practical aspects related to the protocols of multimodal physiotherapy and specially on the education component. Outcome measures included pain intensity (pain intensity numerical rating score), catastrophizing, kinesiophobia, disability and quality of life.

Registry
clinicaltrials.gov
Start Date
February 26, 2018
End Date
January 25, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jorge Fuentes

Principal investigator

Universidad Católica del Maule

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Kinesiophobia

Time Frame: From baseline to the end of intervention (8 weeks)

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

Change Pain intensity: visual analogue scale

Time Frame: From baseline to the end of intervention (8 weeks)

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.

Pain catastrophizing

Time Frame: From baseline to the end of intervention (8 weeks)

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

Disability

Time Frame: From baseline to the end end of intervention (8 weeks)

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.

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

Time Frame: From baseline to the end of intervention (8 weeks)

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.

Study Sites (1)

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