The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

Official title: The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Chronic Low Back Pain

Status Recruiting

Clinical Trial 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 Chronic Low Back Pain. The following question will be answered in this research Q1: Is acute bout of exercise effective in reducing pain among adults with Chronic Low Back Pain? Participants who agree to participate and sign the informed consent will be randomized 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).

Clinical Trial Description

Low back pain (LBP) is a common condition that affects many people at some point in their lives. It is estimated that between 5.0% and 10.0% of cases develop chronic low back pain (CLBP), which causes high treatment costs, cessation of work, and suffering. Suffering from LBP is considered one of the main reasons for seeking medical services. Chronic back pain also negatively affects a person's psychological status, in addition to affecting the productivity of workers among them. Exercise training is a fundamental treatment modality for chronic low back pain, knee osteoarthritis, 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 these barriers 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 CLBP, fibromyalgia, and knee osteoarthritis. Research Questions: Is a single bout of exercise effective in improving pain sensitivity and clinical pain in adults with CLBP? Gaps in Existing Knowledge: It is not clear whether a single bout of exercise results in a clinically meaningful reduction in pain sensitivity or clinical pain intensity in people with CLBP. Research Methods: Research design: The design of this study will be a randomized controlled trial. The recruited participants will be assessed for eligibility by one of the physiotherapists. Participants: Ninety participants will be recruited from King Abdullah Hospital, Bisha, Kingdom of Saudi Arabia. This RCT study will recruit participants who are: 1. aged 18 years or older; and 2. diagnosed with chronic non-specific LBP (lasting for more than 12 weeks). The exclusion criteria are: 1. pregnancy. 2. patients who have neurological compromise (e.g., cauda equine syndrome or spinal nerve compromise). 3. Patients who have spinal pathologies (e.g., fracture, ankylosing spondylitis) 4. Uncontrolled diabetic. 5. who has any history of heart disease (e.g., myocardial infarction, embolism) 6. Orthopaedic impairment (e.g., balance problems) Interventions Eligible participants who agree to participate and sign the informed consent will be randomized 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), Outcomes 1. Pain pressure threshold (difference = exercise-induced hypoalgesia). It will be measured using a digital pressure algometer, FDX®️ (Wagner instrument, Greenwich, USA). 2. Clinical pain at rest (visual analog scale (VAS; 0-10)): functional pain (VAS associated with previously painful movement), expectations of treatment effect. The outcomes will be measured before (baseline) and immediately after the exercise session. Methods Ethics Prior to conducting the study, the research proposal will be submitted to the ethical committee at Taif University to obtain approval to conduct the study. The ethical approval will also be taken from General Administrative for Research & Studies at the Directorate of Health Affairs in Bisha. Consent 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 Abdulah Hospital in Bisha, Saudi Arabia. Sample size: Based on sample size calculation following a pilot study conducted in our lab, we plan to enroll 90 participants in the study with symptomatic Chronic Low Back Pain. 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 a 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. Participants who have numbers 2, 5, 8 and etc will be in group 3 whereas participants who have numbers 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 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. ;

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

• NCT number: NCT05779748
• Study type: Interventional
• Source: Taif University
• Contact: Mutlaq Alswat, BSc
• Phone: 00966552888869
• Email: alswat.m.m@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Completion date: April 5, 2023