NCT05568758

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 8, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

October 1, 2022

Last Update Submit

November 7, 2022

Conditions

Outcome Measures

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

    4 weeks

Secondary Outcomes (1)

  • Functional disability level

    4 weeks

Other Outcomes (1)

  • Lumbar spine mobility

    4 weeks

Study Arms (2)

Thoracic lymphatic pump technique

EXPERIMENTAL

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 techniqueOther: Exercises (stretching and strenghtening )

exercises

EXPERIMENTAL

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

Other: Exercises (stretching and strenghtening )

Interventions

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.

Thoracic lymphatic pump technique

stretching exercises include: Hamstring stretching exercises Lower back stretching exercises : strenghtening exercises include: Abdominal curl up exercises : Supine bridging exercises. Trunk extension exercises

Thoracic lymphatic pump techniqueexercises

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basma Hesham

Giza, 12111, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Basma Hesham, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

October 1, 2022

First Posted

October 6, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

November 8, 2022

Record last verified: 2022-10

Locations