Low Back Pain, MechanicalNCT05568758
Thoracic Lymphatic Pump Technique Exercises Chronic Mechanical Low Back Pain
A study testing Thoracic lymphatic pump technique and Exercises (stretching and strenghtening ) in people with Low Back Pain, Mechanical, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Thoracic lymphatic pump technique and Exercises (stretching and strenghtening )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Basma Hesham
Giza, 12111
Basma Hesham, Doctoral, 01001609596, basmahesham44@gmail.com
About this study
Official title: Effects of Combining Thoracic Lymphatic Pump Technique and Exercises on Patients With Chronic Mechanical Low Back Pain
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.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Thoracic lymphatic pump technique, Exercises (stretching and strenghtening )
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic lymphatic pump techniqueOther
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 )Other
stretching exercises include: Hamstring stretching exercises
Lower back stretching exercises :
strenghtening exercises include:
Abdominal curl up exercises :
Supine bridging exercises. Trunk extension exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Thoracic lymphatic pump technique; Other: Exercises (stretching and strenghtening ) |
| exercises | Experimental | Stretching exercises (hamstring stretch-lower back stretch) Strenghening exercises(abdominal curl up-supine bridging-trunk extension) Receives: Other: Exercises (stretching and strenghtening ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Hesham Hasaneen EL-Fayoumi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568758
- Sponsor's protocol ID
- Thorac lymph exercises back
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combining Thoracic Lymphatic Pump Technique and Exercises on Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05568758
- Acronym / sponsor ID
- Thorac lymph exercises back
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic lymphatic pump technique | Experimental | Other: Thoracic lymphatic pump technique, Other: Exercises (stretching and strenghtening )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 | Experimental | Other: Exercises (stretching and strenghtening )Stretching exercises (hamstring stretch-lower back stretch) Strenghening exercises(abdominal curl up-supine bridging-trunk extension) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic lymphatic pump techniqueThe 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 |
| 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 | Other | Thoracic lymphatic pump technique, exercises |
Primary outcome
Pain intensity
Time frame: 4 weeks
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
1 secondary outcome
Functional disability level
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic lymphatic pump technique and Exercises (stretching and strenghtening ) in people with Low Back Pain, Mechanical, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basma Hesham, Doctoral (01001609596, basmahesham44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.