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Thoracic Lymphatic Pump Technique Exercises Chronic Mechanical Low Back Pain

Primary Purpose

Low Back Pain, Mechanical

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic lymphatic pump technique
Exercises (stretching and strenghtening )
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Basma HeshamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thoracic lymphatic pump technique

exercises

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Pain intensity
Arabic version of the Visual analogue scale (VAS) will be used, the subject will mark on a 0-10 graphic rating scale in which the (0) value indicating no pain, and (10) indicating the most severe pain experienced. Then a ruler will be used to measure the distance from zero, the recorded number will be rounded to the closest value

Secondary Outcome Measures

Functional disability level
Functional disability level will be assessed by Oswestary disability index (ODI) which is a clinical assessment tool that provides an estimate of disability expressed as a percentage score. It consists of ten sections that assess pain, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life and travelling. It consists of ten multiple choice questions for back pain; patient selects one sentence out of six of the best describes her/his pain. High scores indicate great pain (Nishant et al., 2014). Arabic version of the questionnaire will be used and the questions are going to be explained to the subjects. For illiterate subjects, the therapist will read and explain the questions for them

Full Information

First Posted
October 1, 2022
Last Updated
November 7, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05568758
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracic lymphatic pump technique
Arm Type
Experimental
Arm Description
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.
Arm Title
exercises
Arm Type
Experimental
Arm Description
Stretching exercises (hamstring stretch-lower back stretch) Strenghening exercises(abdominal curl up-supine bridging-trunk extension)
Intervention Type
Other
Intervention Name(s)
Thoracic lymphatic pump technique
Intervention Description
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
Intervention Name(s)
Exercises (stretching and strenghtening )
Intervention Description
stretching exercises include: Hamstring stretching exercises Lower back stretching exercises : strenghtening exercises include: Abdominal curl up exercises : Supine bridging exercises. Trunk extension exercises
Primary Outcome Measure Information:
Title
Pain intensity
Description
Arabic version of the Visual analogue scale (VAS) will be used, the subject will mark on a 0-10 graphic rating scale in which the (0) value indicating no pain, and (10) indicating the most severe pain experienced. Then a ruler will be used to measure the distance from zero, the recorded number will be rounded to the closest value
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Functional disability level
Description
Functional disability level will be assessed by Oswestary disability index (ODI) which is a clinical assessment tool that provides an estimate of disability expressed as a percentage score. It consists of ten sections that assess pain, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life and travelling. It consists of ten multiple choice questions for back pain; patient selects one sentence out of six of the best describes her/his pain. High scores indicate great pain (Nishant et al., 2014). Arabic version of the questionnaire will be used and the questions are going to be explained to the subjects. For illiterate subjects, the therapist will read and explain the questions for them
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Lumbar spine mobility
Description
Modified-Modified Schober test (MMST) which is a valid and reliable tool, is used to assess lumbar spine mobility through flexion, extension movements
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basma Hesham, Doctoral
Phone
01001609596
Email
basmahesham44@gmail.com
Facility Information:
Facility Name
Basma Hesham
City
Giza
ZIP/Postal Code
12111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basma Hesham, Doctoral
Phone
01001609596
Email
basmahesham44@gmail.com

12. IPD Sharing Statement

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Thoracic Lymphatic Pump Technique Exercises Chronic Mechanical Low Back Pain

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