Clinical trial NCT05568758: Thoracic Lymphatic Pump Technique Exercises Chronic Mechanical Low Back Pain
Official title: Effects of Combining Thoracic Lymphatic Pump Technique and Exercises on Patients With Chronic Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Mechanical
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare between the combined effect of thoracic lymphatic pump technique with exercises and exercises alone on pain intensity using Visual Analogue Scale (VAS), lumbar spine mobility using Modified-Modified Schober test (MMST) and functional disability level using Oswestary Disability Index (ODI) on patients with CMLBP.

Detailed description: Study design: This study will be randomizaed controlled trail.1. Participants:forty-two patients with chronic mechanical low back pain. age:20-45. Th sample size population: was calculated using the G\*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany) for one tailed test. Sample size calculation based on F tests (ANOVA: Special effects and interactions), Type I error (a) = 0.05, power (1-ß error probability) = 0.80, Pillai V = 0.3300000 and effect size f (V) = 0.8 with 2 independent groups comparison for 3 major variable outcomes. The appropriate minimum sample size for this study was 42 patients (21 patients in each group). Procedure:First, the purpose of the study will be explained to the patients and the procedures are fully explained. Then, patients will be asked to participate in the study. If they accepted, an informed consent form will be signed and randomly assigned in one of two groups (by closed envelope method). All subjects will be evaluated for their pain intensity,lumbar spine mobility and functional disability level. All patients will be tested before and after the treatment program (12 treatment sessions, 3 sessions per week for 4 weeks). Each patient will receive exercises (stretching and strengthening exercises) for the control group (A), the stretching exercises include (Hamstring stretching- Lower back stretching) and the strengthening exercises- include (Abdominal curl up- Supine bridging-Trunk extension). For the experimental group (B), they will receive exercises (stretching and strengthening exercises) then the thoracic lymphatic pump technique.

Eligibility criteria: Inclusion Criteria:

* Patients (both genders) with a chief complain of Chronic mechanical low back pain without leg pain (Al Sulaimy et al., 2018).
* Age of the patient 20- 45 years old (Al Sulaimy et al., 2018).
* Pain more than three months

Exclusion Criteria:

* Patient with Spondylolysis (Steele et al., 2016).
* Patient with tumor, infection (Ulger et al., 2017).
* Patient with cauda equina syndrome who need urgent surgery (Ulger et al., 2017).
* Patients with previous lumber surgery (Amundsen et al., 2018).
* Patient with Deep venous thrombosis (DVT) (Alves et al., 2020).
* Patient with Congestive heart failure (Alves et al., 2020).
* Patient with Renal failure (Forner-Cordero et al., 2021).
* Patient with uncontrolled hypertension (Forner-Cordero et al., 2021).

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional disability level
timeFrame: 4 weeks
Other outcomes:
measure: Lumbar spine mobility
timeFrame: 4 weeks
Locations:
city: Giza
country: Egypt
facility: Basma Hesham
Study officials:
References: