Algo K Specific Manual Therapy for Sub Acute Low Back Pain With Radicular Symptoms

NCT07118033 | Not Yet Recruiting

• 2 other identifiers: APHP2308582024-A01892-45
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effectiveness of a specific manual therapy approach based on the Algo-K decision algorithm in patients with subacute low back pain radiating to the lower limb. Algo-K helps select the most suitable lumbar mobilization technique according to the patient's pain response. The experimental group will receive a five-minute targeted manual therapy in addition to standard physiotherapy, while the control group will receive a non-specific mobilization. The study aims to determine whether this algorithm-guided intervention leads to faster and greater improvement in pain and disability.

Conditions

Sub Acute Low Back Pain With Radiating Symptoms

Keywords

Low back pain; Manual therapy; Physiotherapy; Decision making

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI, %)

  Patient-reported disability (ODI French version)

  Baseline day to 26-30

Secondary Outcomes (3)

• Oswestry Disability Index (ODI, %)

  day 52-60 /or visit 12

• Pain intensity (numeric rating scale, 0-10)

  Baseline day 26-30 ; day 52-60 /or visit 12

• Pain topography (body diagram score)

  Baseline day 26-30 ; day 52-60 /or visit 12

Study Arms (2)

Specific manual therapy

EXPERIMENTAL

Usual exercise based physiotherapy + 5 min lumbar PA mobilisations chosen with Algo K algorithm based on symptom response

Procedure: Specific Manual Therapy

Non specific manual therapy

SHAM COMPARATOR

Same physiotherapy + 5 min PA mobilisations in upper thoracic spine, distant from symptoms

Procedure: Non specific Manual Therapy

Interventions

Specific Manual Therapy PROCEDURE

Participants in this group receive a standardized physiotherapy program (exercise and education) plus 5 minutes of targeted lumbar postero anterior mobilizations. These mobilizations are selected using the Algo K decision algorithm, which guides the therapist to choose the most appropriate technique based on the patient's pain response during preliminary movement tests.

Specific manual therapy

Non specific Manual Therapy PROCEDURE

Participants in this group receive the same physiotherapy program, but the additional 5 minutes of mobilization are applied to the upper thoracic spine (T4-T7), away from the symptomatic lumbar region. This sham mobilization mimics the manual therapy without targeting the affected area or following the algorithm's logic.

Non specific manual therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 65 y o
• Sub acute low back pain (7 days - 3 months) with irradiation to one lower limb, pain 3 10/10
• Mechanically responsive pain
• ODI \> 20 % and \< 80 %
• Prescription ≥ 12 physiotherapy sessions (or un specified)
• Able to complete 12 sessions in ≤ 60 days
• Affiliated to French social security
• Signed informed consent

You may not qualify if:

• Suspicion or history of serious pathology (cancer, systemic inflammatory disease, etc.)
• Main complaint other than low back pain with irradiation
• Prior spine or hip surgery (no time limit) / thoraco abdominal surgery \< 3 y
• Central Sensitization Inventory ≥ 37
• HAD anxiety or depression sub score ≥ 8
• Planned lumbar infiltration during follow up
• Pregnancy or breastfeeding
• Legal protection (guardianship, custody, imprisonment)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• valerie VACHER

  DRCI-AP-HP, Saint-Louis Hospital

  STUDY CHAIR

Central Study Contacts

Sebastien MARTIN, PT, MSc

CONTACT

0612729653; s.urfamartin@gmail.com

Romain ARTICO, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients unaware of allocation ; sham mobilization in control arm
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups, both of them will execute the same standard physiotherapy care based on exercise and education for 25 minutes for each session, randomly assigned 1:1. For the control group, they will have a 5 minutes postero-anterior mobilisation procedure on a upper thoracic vertebra For the interventional group, they will have a 5 minutes postero-anterior mobilisation procedure on a lumbar vertebra, determined by the algorithm

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share