Pain Neuroscience Education in Patients With Total Knee Arthroplasty

Sponsor
Ahi Evran University Education and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05928351
Collaborator
(none)
34
1
2
6
5.7

Study Details

Study Description

Brief Summary

The aim of Pain Neuroscience Education (PNE) is to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement in musculoskeletal problems. Knee osteoarthritis (KOA) is a very common painful musculoskeletal problem, especially in people over 50 years old, and lead to decrease in knee range of motion. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, poor outcomes are common. The lack of satisfactory results suggests that some practices should be revised. Although PNE could be useful as an intervention, to our knowledge, there is no randomized controlled trial in the literature investigating the effects of PNE in patients with a KOA. Therefore, we aimed to examine the effectiveness of PNE on clinical outcomes in patients with KOA.

Condition or Disease Intervention/Treatment Phase
  • Other: Pain Neuroscience Education
  • Other: Standard Physiotherapy Program (SPP)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RandomizedRandomized
Masking:
Single (Outcomes Assessor)
Masking Description:
the blinded assessor
Primary Purpose:
Treatment
Official Title:
Investigation of the Efficacy of Neuroscience Pain Education in Patients With Total Knee Arthroplasty
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PNE Group

Pain Neuroscience Education + Standard Physiotherapy Program

Other: Pain Neuroscience Education
The experimental group will follow a PNE protocol based on previous procedure for 6 weeks in addition to the standard physiotherapy program (SPP) in postoperative period. Each PNE session will take 45-60 min. PNE will be conducted in line with international guidelines and covered the neurophysiology of pain, transition from acute to chronic pain, and the nervous system ability to modulate the pain experience.

Other: Standard Physiotherapy Program (SPP)
The control group will follow a SPP. The 45-minute-long treatment sessions will be held 5 days per week. The treatment program will be organized in 3 periods as 0-2 weeks, 3-4 weeks and 5-6 weeks. The overall treatment program will include scar massage, patellar mobilization, coldpack, ankle pump, quadriceps and hamstring strengthening, hip range of motion, hip strengthening exercises, squat, ascending and descending stairs, walking training. All exercises will be 10 repetitions x 2 sets.

Active Comparator: Control Group

Standard Physiotherapy Program

Other: Standard Physiotherapy Program (SPP)
The control group will follow a SPP. The 45-minute-long treatment sessions will be held 5 days per week. The treatment program will be organized in 3 periods as 0-2 weeks, 3-4 weeks and 5-6 weeks. The overall treatment program will include scar massage, patellar mobilization, coldpack, ankle pump, quadriceps and hamstring strengthening, hip range of motion, hip strengthening exercises, squat, ascending and descending stairs, walking training. All exercises will be 10 repetitions x 2 sets.

Outcome Measures

Primary Outcome Measures

  1. Pain severity [Baseline]

    Visual Analogue Scale (0-10, higher means worse)

  2. Pain severity change is being assessed [6 week]

    Visual Analogue Scale (0-10, higher means worse)

  3. Pain and Function [Baseline]

    Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)

  4. Pain and Function change are being assessed [6 week]

    Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)

  5. Pain and Function [Baseline]

    Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)

  6. Pain and Function change are being assessed [6 week]

    Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)

Secondary Outcome Measures

  1. Pain Catastrophizing [Baseline]

    Pain Catastrophizing Scale (0-52, higher means worse)

  2. Pain Catastrophizing change is being assessed [6 week]

    Pain Catastrophizing Scale (0-52, higher means worse)

  3. Kinesiophobia [Baseline]

    Tampa Scale of Kinesiophobia (17-68, higher means worse)

  4. Kinesiophobia change is being assessed [6 week]

    Tampa Scale of Kinesiophobia (17-68, higher means worse)

  5. Level of quality of life [Baseline]

    Short Form-12 (0-100, higher means better)

  6. Level of quality of life change is being assessed [6 week]

    Short Form-12 (0-100, higher means better)

  7. Anxiety and Depression [Baseline]

    Hospital Anxiety Depression Scale (0-21, higher means worse)

  8. Anxiety and Depression change is being assessed [6 week]

    Hospital Anxiety Depression Scale (0-21, higher means worse)

  9. Physical Function [Baseline]

    40 meter walking test (in seconds, less is better)

  10. Physical Function change is being assessed [6 week]

    40 meter walking test (in seconds, less is better)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Having a body mass index between 19-40 kg/m2,

  • Having had a unilateral TKA,

  • Knee pain score to be 4 and above daily according to the visual analog scale,

  • Ability to read, speak and understand Turkish.

Exclusion Criteria:
  • Prosthesis disorders requiring re-surgery,

  • Having visual, auditory and cognitive impairment,

  • Secondary TKA such as rheumatoid arthritis,

  • Acute pain,

  • Pregnancy, drug and alcohol use,

  • Having bilateral TKA,

  • Not volunteering to participate in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahi Evran University Kırşehir Central Turkey 40080

Sponsors and Collaborators

  • Ahi Evran University Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdulhamit Tayfur, Principal Investigator, Ahi Evran University Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05928351
Other Study ID Numbers:
  • 2023/605
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abdulhamit Tayfur, Principal Investigator, Ahi Evran University Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023