- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07641972
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction in Lumbar Spine Radiculopathy.
10. juni 2026 opdateret af: Riphah International University
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction on Pain, Lumbar Mobility and Functional Disability in Patients With Lumbar Spine Radiculopathy.
Recruitment: Individuals with the lumbar spine radiculopathy diagnosis will undergo screening to determine their eligibility based on inclusion and exclusion criteria.
Eligible participants will be asked for their informed consent.
Enrollment: Participants will receive a unique identifying code to maintain confidentiality and be formally enrolled in the study upon obtaining informed consent.
Following that, they will have baseline evaluations for outcome factors such as numeric pain rating scale, Oswestry disability index, and modified-modified Schober test.
After completing the baseline evaluation, participants will be divided into two groups: Group A will receive the Mulligan's spinal mobilization with leg movement, while Group B will receive mechanical lumbar traction.
Every participant will get treatment for four weeks, with three sessions per week.
At the conclusion of the intervention period, a post-intervention assessment will be carried out.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Recruitment: Individuals with the lumbar spine radiculopathy diagnosis will undergo screening to determine their eligibility based on inclusion and exclusion criteria.
Eligible participants will be asked for their informed consent.
Enrollment: Participants will receive a unique identifying code to maintain confidentiality and be formally enrolled in the study upon obtaining informed consent.
Following that, they will have baseline evaluations for outcome factors such as numeric pain rating scale, Oswestry disability index, and modified-modified Schober test.
After completing the baseline evaluation, participants will be divided into two groups: Group A will receive the Mulligan's spinal mobilization with leg movement, while Group B will receive mechanical lumbar traction.
Every participant will get treatment for four weeks, with three sessions per week.
At the conclusion of the intervention period, a post-intervention assessment will be carried out.
Randomization: Random allocation of participants into the two groups, Group A and Group B, will be performed by a lottery method.
The participants of Group A will be managed by Mulligan's spinal mobilization with leg movement while in Group B, participants will receive mechanical lumbar traction.
The physiotherapists will provide both interventions during a specified period.
Blindness: A single blinded study in which patients will be blinded.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Middle Age 25 to 50 years
- Both male and female of middle aged
- Subacute or chronic lumbar radiculopathy lasting 4 to 12 weeks
- Clinically diagnosed lumbar spine radiculopathy
- Pain radiating from lumbar region to the leg in one or more dermatomal distribution of the lumbosacral nerve root
- Moderate functional disability as indicated by Oswestry Disability Index (ODI) >20%
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Acute pain (<4 weeks)
- Contraindications to manual therapy or traction such as spinal instability
- significant musculoskeletal conditions, cerebrovascular accidents, psychiatric illness, or major systemic illness
- Neurological compromised, other radicular pain (e.g., piriformis syndrome, diabetic radiculopathy, vascular impingement of the sciatic nerve)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Spinal Mobilization With Leg Movement
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Group A: Mulligan's spinal mobilization with leg movement with Conventional Therapy Patient Position: The participants were positioned in a side-lying position on their unaffected side, close to the edge of the treatment table.
Therapist Position: The affected leg was supported by therapist B and extended with a slight abduction of 10° at the hip and a knee flexion of 45°.Application of Technique: Therapist A applied and sustained a transverse glide of the spinous process toward the floor.
The participants actively moved the leg into the SLR with therapist B's assistance.
The L4 vertebra was selected if the participant had an L4/L5 lesion.
Therapist A carefully assisted the participants to perform active SLR in a gliding position with the help of therapist B to avoid symptom recurrence during movement.
If pain recurred, the participant was instructed to relax and hold the position for 3 s, and then return to the starting point(29).
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Aktiv komparator: conventional therapy
5 minutes conventional therapy with patient education will be given to participants of both groups according to the severity of their condition along with allocated intervention.
This includes; directional preference exercises (e.g., McKenzie), core activation exercises, trunk and hip muscles strengthening and neurodynamic mobilization if nerve symptoms persist.
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Group B: Mechanical Lumbar Traction with Conventional Therapy Patient Position: Patient position supine (lying on the back) with hips and knees flexed (pillows under the knees).
However, prone (lying on the stomach) positioning can also be utilized, particularly when the patient experiences discomfort or when targeting anterior structures of the spine.
Traction Technique: Mechanical lumbar traction is a technique that uses a machine to apply a controlled, distracting force to the lumbar spine.
This can help relieve pressure on the spinal nerves, reduce muscle spasms, and improve spinal alignment.
It's typically performed using a traction table and harnesses to gently pull the lower body away from the upper body.
Duration: For lumbar traction, sessions usually range from 20 to 30 minutes, with a frequency of several times per week(30).
Warm Up: 5minutes warm-up will be given before intervention to participants of both groups.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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numeric pain rating scale
Tidsramme: Baseline to 4 weeks
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NUMERIC PAIN RATING SCALE (NPRS) The Numeric Rating Scale (NRS) is a validated tool used to measure pain intensity.
Patients will be asked to rate their current pain severity on a scale from 0 to 10. Scoring can be obtained by calculating the mean score over a period of time or by tracking individual scores
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Baseline to 4 weeks
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Lumbar Mobility
Tidsramme: Baseline to 4 weeks
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OSWESTRY DISABILITY INDEX (ODI) The ODI is a ten-item questionnaire that assesses how back pain affects the patient's ability to perform daily activities of life (ADL).
It is a reliable and valid self-reported questionnaire that lasts 5 min for the patient to complete the measure and a few minutes for the examiner to calculate the scores.
Each item is scored from 0 to 5, and the summation of the ten scores is stated as a percentage of the maximum score; therefore, it ranges from 0 (no disability) to 100 (maximum disability)
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Baseline to 4 weeks
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Functional Disability
Tidsramme: Baseline to 4 weeks
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MODIFIED MODIFIED SCHOBER TEST (MMST) The Modified Modified Schober Test (MMST) is a clinical assessment of lumbar spine mobility where two marks are made on the patient's back-one at the midpoint between the posterior superior iliac spines (PSIS) and another 15 cm above it.
The patient then bends forward maximally, and the increase in distance between the marks is measured; a normal increase is ≥5 cm, while reduced expansion suggests restricted lumbar flexion, as seen in conditions like ankylosing spondylitis, degenerative disc disease, or radiculopathy.
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Baseline to 4 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Tazeem Afzal, Ms, Riphah International University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. juni 2025
Primær færdiggørelse (Anslået)
6. august 2026
Studieafslutning (Anslået)
4. september 2026
Datoer for studieregistrering
Først indsendt
8. juni 2026
Først indsendt, der opfyldte QC-kriterier
10. juni 2026
Først opslået (Faktiske)
11. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REC/RCR & AHS/25/0212
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