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

Not Applicable

Completed

• Conditions: Rotator Cuff Injuries
• Interventions: Behavioral: Pain Neuroscience Education; Behavioral: Biomedical Education

• Registration Number: NCT04522934
• Lead Sponsor: Universidad Católica del Maule

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.

Study Timeline

• Study Start: 2018-02-26
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Status Verified: 2020-08
• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Study First Posted: 2020-08-21
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Neuroscience Education	Pain Neuroscience Education	Patients received 24 sessions, in a 8-week period, of multimodal physiotherapy along with four sessions of pain neuroscience education.
Biomedical Education	Biomedical Education	Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy along with four sessions of biomedical education.

Primary Outcome Measures

Name	Time	Method
Kinesiophobia	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	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	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	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	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.

Trial Locations

Locations (1)

Hospital de Temuco; 🇨🇱 Temuco, Araucania, Chile