Pain Neuroscience Education in Patients With Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:

Investigation of the Efficacy of Neuroscience Pain Education in Patients With Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05928351
• Other study ID #: 2023/605
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Ahi Evran University Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Ahi Evran University	Kirsehir	Central

Sponsors (1)

Lead Sponsor	Collaborator
Ahi Evran University Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Louw A PT, PhD, Zimney K PT, DPT, Reed J PT, DPT, Landers M PT, DPT, PhD, Puentedura EJ PT, DPT, PhD. Immediate preoperative outcomes of pain neuroscience education for patients undergoing total knee arthroplasty: A case series. Physiother Theory Pract. 2019 Jun;35(6):543-553. doi: 10.1080/09593985.2018.1455120. Epub 2018 Mar 28. — View Citation

Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity	Visual Analogue Scale (0-10, higher means worse)	Baseline
Primary	Pain severity change is being assessed	Visual Analogue Scale (0-10, higher means worse)	6 week
Primary	Pain and Function	Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)	Baseline
Primary	Pain and Function change are being assessed	Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)	6 week
Primary	Pain and Function	Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)	Baseline
Primary	Pain and Function change are being assessed	Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)	6 week
Secondary	Pain Catastrophizing	Pain Catastrophizing Scale (0-52, higher means worse)	Baseline
Secondary	Pain Catastrophizing change is being assessed	Pain Catastrophizing Scale (0-52, higher means worse)	6 week
Secondary	Kinesiophobia	Tampa Scale of Kinesiophobia (17-68, higher means worse)	Baseline
Secondary	Kinesiophobia change is being assessed	Tampa Scale of Kinesiophobia (17-68, higher means worse)	6 week
Secondary	Level of quality of life	Short Form-12 (0-100, higher means better)	Baseline
Secondary	Level of quality of life change is being assessed	Short Form-12 (0-100, higher means better)	6 week
Secondary	Anxiety and Depression	Hospital Anxiety Depression Scale (0-21, higher means worse)	Baseline
Secondary	Anxiety and Depression change is being assessed	Hospital Anxiety Depression Scale (0-21, higher means worse)	6 week
Secondary	Physical Function	40 meter walking test (in seconds, less is better)	Baseline
Secondary	Physical Function change is being assessed	40 meter walking test (in seconds, less is better)	6 week