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

Rotator Cuff Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522934
• Other study ID #: Neuroscience Rotator Cuff
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: August 2020
• Source: Universidad Católica del Maule
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

Behavioral:
• Pain Neuroscience Education
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.
• Biomedical Education
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.

Locations

Country	Name	City	State
Chile	Hospital de Temuco	Temuco	Araucania

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica del Maule

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)