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Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction in Lumbar Spine Radiculopathy.

10 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Spinal Mobilization With Leg Movement
Autre: Spinal Mobilization With Leg Movement
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).
Comparateur actif: 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.
Autre: Mechanical Lumbar Traction
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
numeric pain rating scale
Délai: Baseline to 4 weeks
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
Baseline to 4 weeks
Lumbar Mobility
Délai: Baseline to 4 weeks
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)
Baseline to 4 weeks
Functional Disability
Délai: Baseline to 4 weeks
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.
Baseline to 4 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Riphah International University

Les enquêteurs

  • Chercheur principal: Tazeem Afzal, Ms, Riphah International University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 juin 2025

Achèvement primaire (Estimé)

6 août 2026

Achèvement de l'étude (Estimé)

4 septembre 2026

Dates d'inscription aux études

Première soumission

8 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

11 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • REC/RCR & AHS/25/0212

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

nill

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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