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

Primary Purpose

Rotator Cuff Injuries

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Pain Neuroscience Education
Biomedical Education
Sponsored by
Universidad Católica del Maule
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Temuco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain Neuroscience Education

Biomedical Education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 16, 2020
Last Updated
August 18, 2020
Sponsor
Universidad Católica del Maule
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1. Study Identification

Unique Protocol Identification Number
NCT04522934
Brief Title
A Pilot Randomized Trial of Pain Neuroscience Education in the Rehabilitation After Arthroscopic Rotator Cuff Repair
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica del Maule

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Neuroscience Education
Arm Type
Experimental
Arm Description
Patients received 24 sessions, in a 8-week period, of multimodal physiotherapy along with four sessions of pain neuroscience education.
Arm Title
Biomedical Education
Arm Type
Active Comparator
Arm Description
Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy along with four sessions of biomedical education.
Intervention Type
Behavioral
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Biomedical Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change Pain intensity: visual analogue scale
Description
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.
Time Frame
From baseline to the end of intervention (8 weeks)
Title
Pain catastrophizing
Description
Pain catastrophic was assessed using the Patient Catastrophizing Scale (PCS), a 52-point self-administered instrument with MCID of 4.5 points.
Time Frame
From baseline to the end of intervention (8 weeks)
Title
Kinesiophobia
Description
Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK-11), a 44-point self-administered instrument with MCID established at 6.0 points
Time Frame
From baseline to the end of intervention (8 weeks)
Title
Disability
Description
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.
Time Frame
From baseline to the end end of intervention (8 weeks)
Title
Health-related quality of life: 5-dimension EuroQol questionnaire
Description
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.
Time Frame
From baseline to the end of intervention (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Ponce, BSc
Organizational Affiliation
Universidad Santo Tomas, Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Temuco
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

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

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