Effect of Conventional Physical Therapy With or Without Diaphragm Manual Therapy in Patients With Chronic Non-Specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Numerical Pain Rating Scale (Pain)
研究概览
简要总结
A randomized single-blind clinical study will be performed. A sample size of 34 patients including only male gender, will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Treatment Group A will perform Conventional Physical Therapy and Diaphragm Manual Therapy and Group B will perform Conventional Physical Therapy and Sham Diaphragm Manual Therapy. Numerical Pain Rating Scale and lumbar range of motion scores will be assessed at pre-treatment, 2nd-week post-treatment and 4th-week post-treatment. Oswestry Disability Index scores and Short Form 12 Health Survey Questionnaire will be assessed at pre-treatment and 4th-week post-treatment. Statistical analysis will be performed on Statistical Package for the Social Sciences Version 25.
详细描述
Over 80% of people experience Lower back pain in their lives, of which 23% suffer from chronic pain. Physiotherapists use multiple treatment options for treating non-specific chronic low back pain such as joint mobilization, therapeutic exercises, electrotherapeutic modalities and soft tissue release techniques.
The objective of the study is to determine the effect of conventional physical therapy with or without diaphragm manual therapy in patients with chronic non-specific low back pain.
A randomized, single-blind clinical study will be performed. A sample size of 34 patients comprising of only male gender will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Treatment Group A will perform Conventional Physical Therapy and Diaphragm Manual Therapy and Group B will perform Conventional Physical Therapy and Sham Diaphragm Manual Therapy. Numerical Pain Rating Scale and lumbar range of motion scores will be assessed at pre-treatment, 2nd-week post-treatment and 4th-week post-treatment. Oswestry Disability Index scores and Short Form 12 Health Survey Questionnaire will be assessed at pre-treatment and 4th-week post-treatment.
Statistical analysis will be performed on Statistical Package for the Social Sciences Version 25. Mean ± Standard Deviation will be used to present Quantitative variables while Qualitative variables will be shown through frequency tables and percentages will be shown in the form of frequency tables and percentages. Summary of group measurements will be represented through Graphs. Normal distribution of data will be analyzed through skewness, kurtosis and Shapiro wilk test. If data is found normally distributed, then parametric tests will be applied, which will include an Independent sample t-test for measuring inter-group changes. Paired Sample t-test/Repeated measure ANOVA for measuring intra-group differences. If data is found non-normally distributed, then non-parametric tests will be applied, which will include Mann-Whitney U-Test for measuring inter-group changes and Wilcoxon Test/Friedman Test for measuring intra-group differences. P-value ≤ 0.05 will be taken as significant.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 20-55 years.
- •Male gender
- •Patients diagnosed as having non-specific chronic low back pain from the last 12 weeks minimum.
- •Pain rating of at least 3 on Numerical Pain Rating Scale.
排除标准
- •Previous history of spinal trauma, fracture or surgery.
- •Patients with lumbar disc herniation and radicular low back pain.
- •Patients having any spinal malignancy, psychological distress, infectious disorder or systemic disorder.
- •Patients with tuberculosis of the spine.
- •Patients with musculoskeletal injuries of the lower extremities.
- •Patients who regularly consume anti-inflammatory or analgesic drugs.
- •Previous history of manual treatment in the last month.
- •Patients having contraindications for manual therapy.
研究组 & 干预措施
Group A
Group A will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Treatment will be provided for a total of four weeks, thrice a week.
干预措施: Manual Diaphragm Technique (Other)
Group A
Group A will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Treatment will be provided for a total of four weeks, thrice a week.
干预措施: Conventional Physical Therapy (Other)
Group B
Group B will receive Conventional Physical Therapy and Sham Diaphragm Technique. Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Treatment will be provided for a total of four weeks, thrice a week.
干预措施: Conventional Physical Therapy (Other)
Group B
Group B will receive Conventional Physical Therapy and Sham Diaphragm Technique. Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Treatment will be provided for a total of four weeks, thrice a week.
干预措施: Sham Diaphragm Manual Technique (Other)
结局指标
主要结局
Change in Numerical Pain Rating Scale (Pain)
时间窗: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Numerical Pain Rating Scale will be used to measure back pain. Score of scale ranges from 0 (no pain) to 10 (worst possible pain).
Change in Universal Goniometer (Lumbar Range of Motion)
时间窗: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Universal Goniometer will be used to measure Lumbar Range of Motion.
次要结局
- Change in Oswestry Disability Index (Back Function Disability)(Change from baseline at 2nd week and Change from 2nd week at 4th week.)
- Change in Short Form 12 Health Survey (Health Related Quality of Life)(Change from baseline at 2nd week and Change from 2nd week at 4th week.)
研究者
M. Ammar Ahmad Sohail
Principal Investigator
University of Faisalabad