Effects of Combining Physiotherapy Group Exercise With Acceptance and Commitment Therapy in Elderly With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
This two-armed randomized controlled trial (RCT) aims to investigate the effectiveness of Group Exercise with acceptance and commitment therapy led by physiotherapist (GrExPACT) (experimental intervention) as compared to Group Exercise alone (GrEx) (control intervention) for elderly with chronic low back pain (LBP) whom are stratified as medium or high-risk using the STarT Back Screening Tool on functional recovery as measured by Roland Morris Disability Questionnaire as the primary outcome and a list of secondary outcomes which include Committed Action questionnaire, Chronic Pain Acceptance questionnaire, Patient self-efficacy Questionnaire, Brief Pain Inventory, Patient Specific Functional Scale, Short Physical Performance Battery and a patient satisfaction survey, immediately after a 5-week programme as well as at 3-month follow-up.
The list of hypotheses to be tested in this RCT include:
- For main effect: Intervention H0: The outcome means for the intervention of GrExPACT and GrEx are equal H1: The outcome means for the intervention of GrExPACT and GrEx are not equal
- For main effect: Time H0: The outcome means for the time with measuring point at pre-intervention, immediate after the program and at 3 months are equal H1: The outcome means for the time with measuring point at pre-intervention, immediate after the program and at 3 months are not equal
- For interaction: Intervention x Time H0: There is no interaction between the intervention and time H1: There is interaction between the intervention and time
详细描述
Sample size:
The sample size was calculated with reference to the effect size of 0.052 (partial eta square) being worked out from the primary outcome of Roland Morris Disability Questionnaire obtained from the pilot study. G*Power 3.1.9.4 was used to calculate the sample size. With power of 0.95 and alpha value of 0.05, the total sample size is 68. With reference to the attrition rate of approximately 20% in the pilot study, the sample size will become 43 subjects in each group and with total of 86 subjects will be recruited.Subjects will be recruited from local community elderly community centers.
Randomization:
The subjects will be randomly assigned by the principal investigator to either intervention group of GrExPACT or control group of GrEx using computerized randomization software. Permuted blocked randomization with a block size of four and stratified by gender and STarT Back category will be used as to ensure the groups are balanced. The allocation will be concealed and stored in an encrypted file storing in a password protected computer. Corresponding group therapy class will be arranged to the patient accordingly.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will be blinded by informing them that they will participate in one of the two treatment groups that is known to be helpful to their chronic nonspecific back pain but not known which one is better. An independent assessor who is responsible for carrying out the physical test and assist the elderly in filling of the questionnaires will be blinded for the group allocation. The research personnel who is responsible for data entry and statistical analysis will also be blinded for the group allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonspecific LBP for > 3 month;
- •Stratified as medium-risk category (i.e., total score ≥ 4 and sub score ≤ to 3) and high-risk category (i.e., total score ≥ 4 and sub score ≥ 4) using the STarT Back Screening Tool;
- •Roland Morris Disability Questionnaire (RMDQ) score ≥ 5 (with reference to the minimal level of detectable change)(30, 31);
- •Able to walk with or without assistive aid and with Modified Functional Ambulatory Category ≥ 6 (32);
- •Able to read Chinese characters;
- •Able to speak and understand Cantonese; and
- •Abbreviated mental test (AMT) ≥ 6 (33).
排除标准
- •Specific cause of LBP such as tumor, infection, or apparent neurological deficit;
- •Serious uncontrolled co-morbidities or systematic diseases which is contraindicated to exercise;
- •Orthopedic condition like recent fracture require immobilization and not fitting for exercise;
- •Unstable cardiac, pulmonary, metabolic, and psychological disease requiring acute care;
- •Severe cognitive, language or hearing deficits;
- •Spinal surgery in the past 12 months as not to confound with effect of surgery;
- •People who had prior treatment with ACT at any time; or
- •People who had received physiotherapy treatment in the previous 6 months.
研究组 & 干预措施
Group Exercise with acceptance and commitment therapy
Combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapist (GrExPACT)
干预措施: GrExPACT (Behavioral)
Group Physiotherapy Exercise alone
Group Physiotherapy exercise alone (GrEx)
干预措施: GrEx (Behavioral)
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: Pre-intervention, immediate post-intervention and 3 month post-intervention
The Roland Morris Disability Questionnaire is a 24 self-administrated items scale which measures the level of disability of patients with LBP. Items are yes and no response in which the item will score 0 with negative response and score 1 for positive response. The score for the Roland Morris Disability Questionaire is the sum of scores of the items with positive response. A patient score can range from 0 to 24. The higher the score, the greater is the disability.
次要结局
- Chronic Pain Acceptance Questionnaire(Pre-intervention, immediate post-intervention and 3 month post-intervention)
- Brief Pain Inventory(Pre-intervention, immediate post-intervention and 3 month post-intervention)
- Short Physical Performance Battery(Pre-intervention, immediate post-intervention and 3 month post-intervention)
- Patient satisfaction Survey(immediate post-intervention)
- Committed Action Questionnaire(Pre-intervention, immediate post-intervention and 3 month post-intervention)
- Patient Specific Functional Scale(Pre-intervention, immediate post-intervention and 3 month post-intervention)
- Pain self-efficacy Questionnaire(Pre-intervention, immediate post-intervention and 3 month post-intervention)