CClinicalTrials.gg
Status unknownNCT05568758Updated Nov 8, 2022

Thoracic Lymphatic Pump Technique Exercises Chronic Mechanical Low Back Pain

An interventional study of Thoracic lymphatic pump technique and Exercises (stretching and strenghtening ) in Low Back Pain, Mechanical, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Low Back Pain, Mechanical
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 42 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Thoracic lymphatic pump technique · Other: Exercises (stretching and strenghtening )

  • Experimental
    exercises

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

    Other: Exercises (stretching and strenghtening )

Interventions

  • OtherThoracic 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.

  • OtherExercises (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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 weeks

Secondary outcomes

  1. 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

    Time frame: 4 weeks

Other outcomes

  1. Lumbar spine mobility

    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

07

Study locations

1 of 1 sites recruiting
  • Basma Hesham
    Giza, 12111, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05568758
Lead sponsor
Cairo University
Responsible party
Basma Hesham Hasaneen EL-Fayoumi (physical therapist, Cairo University) — Principal investigator
First posted
Oct 6, 2022
Start date
Oct 1, 2022
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Nov 8, 2022

Study contacts

Basma Hesham, Doctoral
Contact
basmahesham44@gmail.com
01001609596

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion