The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Knee Osteoarthritis

Sponsor

Taif University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05605444

Collaborator

(none)

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

25.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this interventional study is to investigate the effectiveness of an acute bout of exercises on pain sensitivity and clinical pain among adults with knee osteoarthritis. The following question will be answered in this research Q1: Is acute bout of exercise effective in reducing pain among adult with knee osteoarthritis?

Participants who agree to participate and sign the informed consent will be randomised to one of three groups:

Group 1: Isometric exercise with neutral language and no verbal suggestion consisting of 1 rep of wall squat, 3 min or to volitional fatigue at 100° knee angle;(n=30).

Group 2: Isometric exercise with neutral language and no verbal suggestion consisting of 3 reps of wall squat, 3 min or to volitional fatigue at 100°degree knee angle, 30 sec rest between rep, ;(n=30).

Group 3 (Control group): true control (do nothing);(n=30).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Other: Single bout of exercise	N/A

Detailed Description

Osteoarthritis (OA) has been defined as losing the function of cartilage which causes inflammation and pain. OA is one of the most common joint diseases affecting both men and women worldwide, with women being more affected than men. A previous report estimated that that OA affects approximately 240 million people globally. Furthermore, the 2016 Global Burden of Disease Study estimated that the global incidence of hip and knee OA is 199 cases per 100,000, with incidence rates varying by region and ethnicity. The economic impact of osteoarthritis is significant, and it continues to increase as the population ages and obesity increases.

The knee OA has more clinical symptoms than any other form of OA. Knee OA results not only in pain, but also causes loss of function, and decreased quality of life. The typical clinical presentation of Knee OA is knee pain, brief morning stiffness (less than 30 minutes), crepitus, bony tenderness, and enlargement without palpable warmth, muscles weakness. Furthermore, people diagnosed with OA commonly report psychological problems such as anxiety and fear of movement. These problems might prevent people from participation in exercise and social events, leading to further physical and social isolation. The prevalence of knee OA is estimated to be about 33% and it is one of the five causes of disability among people, especially in the elderly individuals.

Alleviating pain is critical to improve the lives of people with Knee OA. Exercise training is a fundamental treatment modality for chronic low back pain, knee osteoarthritis OA and fibromyalgia. However, pain intensity, kinesiophobia and low self-efficacy are barriers to initiating and adhering to an exercise training program. Therefore, an effective strategy to reduce pain intensity, kinesiophobia and increase self-efficacy to facilitate participation in an exercise training program for people with chronic musculoskeletal pain conditions is important. A single acute bout of exercise can produce a consistent reduction in pain sensitivity, termed exercise induced hypoalgesia, in pain-free populations. Although, the hypoalgesia response is likely dependent on the exercise mode or prescription variables applied. In chronic pain populations, exercise induced hypoalgesia is not always consistent, the optimal exercise dose is largely unknown and there are few studies in people with chronic low back pain, fibromyalgia and knee OA. It is not clear whether a single bout of exercise results in a clinically meaningful reduction in pain sensitivity or clinical pain intensity in these population groups. Pilot data from our lab showed adults with chronic low back pain (n=21) reduced pain sensitivity (via pain pressure threshold) globally (Cohen's d=0.5; medium effect), local to the site of pain (low back; d=0.5; medium effect) and distal to the site of pain (leg; d=0.8; large effect) following a single wall squat (100° knee angle) for three minutes or until volitional fatigue. Given these promising results, exploring the utility of this approach in a controlled clinical setting across a range of common chronic pain conditions is warranted to establish efficacy.

Methods Ethics Prior conducting the study, the research proposal will be submitted to the ethical committee at Taif University to obtain the approval to conduct the study. The ethical approval will also be taking from General Administrative for Research & Studies at Directorate of Health Affairs in Makkah. This study will follow the Declarations of Helsinki(21). Consents will be obtained from the patients before participating in the study.

Study design:

This study design will be a randomized controlled trial with a pre-post control design.

Settings:

The trial will be performed at the Department of Physiotherapy at King Abdul-Aziz Hospital in Makkah in Saudi Arabia.

Sample size:

Based on sample size calculation following pilot study conducted in our lab, we plan to enroll 90 participants in the study with symptomatic knee osteoarthritis. Participants will be randomly divided into three groups. Each group contains 30 individuals. The aim is to achieve 90% power to observe a significant difference of 5% (alpha of 0.05) using a two-tailed t-test.

Sampling techniques:

Participants will be recruited using consecutive sampling technique. Simple randomization will be used to allocate participants in each group. All participants will be given numbers from 1 to 100. Participants who have 1, 4, 7 and etc will be in group 1. Participates who have number 2, 5, 8 and etc will be in group 3 whereas participants who have number 3,6, 9 and etc will be in group 3.

Data analysis:

Data will be analyzed using Statistical Package for Social Sciences (SPSS) version 22. Sociodemographic variables and clinical characteristics will be described by means, standard deviations and frequencies. Generalized linear models will be used to evaluate the effect of the treatment on the outcomes. The statistical analysis will be conducted by an investigator who will be blinded to the subject's intervention group.

Safety and adverse events:

Exercise programs are generally safe; however, it is possible that participants may experience some unforeseen problems such as muscle soreness, falls or other injuries. Participants will be closely monitored to keep track of any unwanted effects or any problems. If there are any unwanted effects the program may be stopped and the reasons will be discussed with the treating physiotherapist and investigator. In case of a serious adverse event, participants will be advised to seek immediate medical assistance.

Funding:

This study did not receive any specific funding.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Knee Osteoarthritis

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 29, 2022

Anticipated Study Completion Date :

Feb 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Isometric exercise-one repetition Isometric exercise consisting of 1 session only. The session will last for around 5 minutes which will include asking the patient to do 1 repetition of wall squat for 3 min or to volitional fatigue at 100° knee angle.	Other: Single bout of exercise isometric wall squat at a knee joint angle of 100 degrees. Instruct participant to place their back against the wall with feet positioned parallel and spaced shoulder-width apart. Lower themselves down until they reached a knee joint angle of 100 degrees. Measure knee joint angle by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm was in line with the lateral malleolus.
Experimental: Isometric exercise-three repetitions Isometric exercise consisting of 1 session only. The session will last for around 10 minutes which will include asking the patient to perform 3 repetition of wall squat (each time the exercise will be performed for 3 min or to volitional fatigue at 100°degree knee angle); patient will be given 30 sec rest between repetitions.	Other: Single bout of exercise isometric wall squat at a knee joint angle of 100 degrees. Instruct participant to place their back against the wall with feet positioned parallel and spaced shoulder-width apart. Lower themselves down until they reached a knee joint angle of 100 degrees. Measure knee joint angle by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm was in line with the lateral malleolus.
No Intervention: Control (no intervention) Will not receive any intervention

Arm

Intervention/Treatment

Experimental: Isometric exercise-one repetition

Isometric exercise consisting of 1 session only. The session will last for around 5 minutes which will include asking the patient to do 1 repetition of wall squat for 3 min or to volitional fatigue at 100° knee angle.

Other: Single bout of exercise

isometric wall squat at a knee joint angle of 100 degrees. Instruct participant to place their back against the wall with feet positioned parallel and spaced shoulder-width apart. Lower themselves down until they reached a knee joint angle of 100 degrees. Measure knee joint angle by placing a goniometer on the lateral epicondyle of the knee, in line with the femur whilst the anchor arm was in line with the lateral malleolus.

Experimental: Isometric exercise-three repetitions

Isometric exercise consisting of 1 session only. The session will last for around 10 minutes which will include asking the patient to perform 3 repetition of wall squat (each time the exercise will be performed for 3 min or to volitional fatigue at 100°degree knee angle); patient will be given 30 sec rest between repetitions.

Other: Single bout of exercise

No Intervention: Control (no intervention)

Will not receive any intervention

Outcome Measures

Primary Outcome Measures

Pain pressure threshold [Change from pre-intervention (baseline) compared to post-intervention (immediately after session)]
The pain will be measured using digital pressure algometer, FDX®️ (Wagner instrument, Greenwich, USA). All trials will be conducted on forearm, lumbar spine and calf sites. There will be at least 20 sec rest before an individual site is tested again. Two trials will be performed at each site. The raw values of each test will be recorded. Because we are testing repeated times, we will use a marker to mark the location of each test site to ensure consistency in location. Algometer must be positioned perpendicular to the measurement site for all trials.
Pain intensity [Change from pre-intervention (baseline) compared to post-intervention (immediately after session)]
It will be measured using Visual Analogue Scale (VAS; 0-10). A rating of zero means that participant don't currently have pain at the low back. A rating of ten on this scale means that the pain at low back is the worst pain. So, the higher the number on this scale means the higher the pain intensity participant is experiencing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 18 years or older.
Diagnosed with unilateral or bilateral symptomatic knee OA.
Have chronic knee pain for three months and more.
Able to perform physical therapy exercise.

Exclusion Criteria:

Pregnancy.
Severe musculoskeletal or neuromuscular disorders or any disease that prevent performing exercises.
Uncontrolled diabetes.
Knee or lower limb surgery.
Sensations problems.
Orthopedic impairment (e.g., balance problems and Fractures in lower limb in the last 6 months).