Comparison of the Immediate Effect of Passive vs. Passive-Active Hamstring Stretching on Flexibility in Patients With Chronic Low Back Pain: Protocol for a Randomized Controlled Trial: EFIM2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Active Knee Extension (AKE)
研究概览
简要总结
The goal of this clinical trial is to determine whether a combination of passive and active hamstring stretching (PAS) is more effective than passive stretching alone (PS) in improving flexibility in patients with chronic low back pain (CLBP).
The main questions it aims to answer are:
Does PAS lead to greater improvements in active flexibility compared to PS? Does PAS provide additional benefits in passive flexibility, hamstring stiffness, and pelvic tilt? Researchers will compare the PAS group and the PS group to see if combining passive and active stretching results in greater improvements in flexibility and movement control.
Participants will:
Perform either PAS or PS stretching exercises as assigned. Undergo measurements of flexibility, hamstring stiffness, and pelvic tilt before and after the intervention.
Answer a question about their perceived change in flexibility following the intervention.
This study aims to improve rehabilitation strategies for people with CLBP, helping them achieve better movement and pain relief.
详细描述
Individuals with chronic low back pain (CLBP) are affected by deficits in hamstring flexibility and lumbopelvic neuromuscular control. While passive hamstring stretching immediately improves passive hamstring flexibility, no clinically important difference in active range of motion has been observed.
The primary objective of the present randomized controlled study protocol is to compare the immediate effects of a novel combination of passive and active stretching (PAS) exercises with passive hamstring stretching (PS) alone on active flexibility.
The secondary objectives include conducting a similar comparison for passive flexibility, hamstring stiffness, and pelvic tilt, as well as estimating the Minimal Clinically Important Difference (MCID) for hamstring flexibility measures. Ninety CLBP patients will be randomized into PAS or PS group and will receive respective interventions. Primary outcome will be the mean value of two measurements of Active Knee Extension taken before and immediately after the intervention. Secondary outcomes, Fingertip-to-Floor distance, Straight Leg Raise, hamstring stiffness and pelvic tilt will be recorded and compared in the same manner. A group-by-time comparison will be conducted for primary and secondary outcomes. An anchor question about perceived by participants change in flexibility following intervention will serve to estimate MCID.
This study protocol is the first opportunity to assess whether combining passive and active hamstring stretching is better than passive stretching alone for achieving an immediate and clinically important improvement in active flexibility among CLBP patients. The results will provide valuable and time-efficient insights for the development of more comprehensive rehabilitation programs in both clinical and research settings.
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 (Outcomes Assessor)
盲法说明
The same investigator will conduct both pre- and post-intervention assessments but will not be involved in administering the intervention for any patient, ensuring they remain blinded to patient allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 and 65 years
- •Suffering from low-back pain for at least 3 months
- •Presenting with hamstring flexibility deficit (Straight Leg Raise <85°, Fingertip-to-Floor distance >5 cm)
排除标准
- •Patients with radicular pain
- •Disc inflammation (MODIC Type 1)
- •Other relevant pathologies (neurological, cardiovascular, respiratory, or oncological diseases)
- •Significant surgical history (e.g., lumbar arthrodesis, knee or hip arthroplasty)
- •Pregnancy or breastfeeding
- •Patients under protective legal measures
结局指标
主要结局
Active Knee Extension (AKE)
时间窗: Before and immediately after the intervention
The Active Knee Extension (AKE) angle will be evaluated at baseline and immediately after the intervention. The mean value of the two measurements taken before the intervention will be compared with the mean value of two measurements taken immediately after the intervention. The change in AKE values of the less flexible lower limb, expressed as a percentage relative to the initial value, will be used to compare the effect between the PS and PAS groups. The participants will extend the tested knee as much as possible while keeping their thigh vertical against a plastic stick placed along the anterior surface of their thigh (maintaining 90° hip flexion). The rater will position the EasyAngle® digital inclinometer on the tibial crest, just below the tibial tuberosity, to record the maximal knee extension angle.
次要结局
- Fingertip-to-Floor distance (FTF)(Before and immediately after the intervention)
- Pelvic tilt angle(Before and immediately after intervention)
- Straight Leg Raise (SLR) angle(Before and immediately after the intervention)
- Hamstring stiffness(Before and immediately after the intervention)
- Pain Visual Analogue Scale (VAS)(Before and immediately after intervention)
- Tampa Scale of Kinesiophobia (TSK-17)(At baseline)
- Score of perceived harmfulness of the movements(At baseline)
- Skin conductance(During pre-intervention evaluation and during intervention.)
- Perceived change in flexibility.(Immediately after the intervention)