Thoracic Lymphatic Pump Technique Exercises Chronic Mechanical Low Back Pain

NCT ID: NCT05568758

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-10-31

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.

Conditions

Low Back Pain, Mechanical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Thoracic lymphatic pump technique

The subject lies in the supine position; the therapist stands at the patient's head, facing the subject. The therapist then, places the thenar eminence of each hand to the pectoral region inferior to the clavicle and the other fingers are spread around the thoracic cage and angled toward the body's side to create a consistent, compressive force across the thoracic cage. The subject is then asked to breathe in deeply and breathe out. While breathing out, rhythmic oscillatory compression in the posterior and caudal direction is applied to the chest wall. By the end of the expiratory phase, the compressive force is maintained, and the subject is asked to take another deep breath. In this way, the subject encountered some resistance equivalent to the chest-wall movement during inspiration. The maneuver is repeated for five respiratory cycles, after that the therapist slowly reduces the compressive force and withdraws his hands.

Group Type: EXPERIMENTAL

Thoracic lymphatic pump technique

Intervention Type: OTHER

The subject lies in the supine position; the therapist stands at the patient's head, facing the subject. The therapist then, places the thenar eminence of each hand to the pectoral region inferior to the clavicle and the other fingers are spread around the thoracic cage and angled toward the body's side to create a consistent, compressive force across the thoracic cage. The subject is then asked to breathe in deeply and breathe out. While breathing out, rhythmic oscillatory compression in the posterior and caudal direction is applied to the chest wall. By the end of the expiratory phase, the compressive force is maintained, and the subject is asked to take another deep breath. In this way, the subject encountered some resistance equivalent to the chest-wall movement during inspiration. The maneuver is repeated for five respiratory cycles, after that the therapist slowly reduces the compressive force and withdraws his hands.

Exercises (stretching and strenghtening )

Intervention Type: OTHER

stretching exercises include: Hamstring stretching exercises

Lower back stretching exercises :

strenghtening exercises include:

Abdominal curl up exercises :

Supine bridging exercises. Trunk extension exercises

exercises

Stretching exercises (hamstring stretch-lower back stretch) Strenghening exercises(abdominal curl up-supine bridging-trunk extension)

Group Type: EXPERIMENTAL

Exercises (stretching and strenghtening )

Intervention Type: OTHER

stretching exercises include: Hamstring stretching exercises

Lower back stretching exercises :

strenghtening exercises include:

Abdominal curl up exercises :

Supine bridging exercises. Trunk extension exercises

Interventions

Thoracic lymphatic pump technique

The subject lies in the supine position; the therapist stands at the patient's head, facing the subject. The therapist then, places the thenar eminence of each hand to the pectoral region inferior to the clavicle and the other fingers are spread around the thoracic cage and angled toward the body's side to create a consistent, compressive force across the thoracic cage. The subject is then asked to breathe in deeply and breathe out. While breathing out, rhythmic oscillatory compression in the posterior and caudal direction is applied to the chest wall. By the end of the expiratory phase, the compressive force is maintained, and the subject is asked to take another deep breath. In this way, the subject encountered some resistance equivalent to the chest-wall movement during inspiration. The maneuver is repeated for five respiratory cycles, after that the therapist slowly reduces the compressive force and withdraws his hands.

Intervention Type: OTHER

Exercises (stretching and strenghtening )

stretching exercises include: Hamstring stretching exercises

Lower back stretching exercises :

strenghtening exercises include:

Abdominal curl up exercises :

Supine bridging exercises. Trunk extension exercises

Intervention Type: OTHER

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Basma Hesham Hasaneen EL-Fayoumi

physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Basma Hesham

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Basma Hesham, Doctoral

Role: CONTACT

basmahesham44@gmail.com

01001609596

Facility Contacts

Basma Hesham, Doctoral

Role: primary

basmahesham44@gmail.com

01001609596

Other Identifiers

Thorac lymph exercises back

Identifier Type: -

Identifier Source: org_study_id