Algo K Specific Manual Therapy for Sub Acute Low Back Pain With Radicular Symptoms (ALGO-K)

Evaluation of the Specificity of a Manual Therapy Based on a Decision Algorithm (Algo-K) in the Physiotherapy Treatment of Sub Acute Low Back Pain With Radiating Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sub Acute Low Back Pain With Radiating Symptoms
• Intervention / Treatment: Procedure: Specific Manual Therapy; Procedure: Non specific Manual Therapy

Detailed Description

Subacute low back pain (LBP) with radiating symptoms is a common musculoskeletal disorder with a risk of chronicization. Manual therapy is often used in physiotherapy to treat LBP, but its effectiveness varies widely due to heterogeneous practices and lack of specificity. The Algo-K algorithm was developed to guide therapists in selecting the most appropriate mobilization technique based on patients' symptomatic responses during movement tests.

This multicenter randomized controlled trial compares the effectiveness of a specific manual therapy guided by the Algo-K algorithm versus a non-specific manual therapy added to a standardized exercise-based physiotherapy program. Sixty adult patients with subacute LBP and radiating pain will be included. Participants will be randomly assigned to either:

• Experimental group: 5 minutes of specific lumbar mobilizations based on the Algo-K decision tree;
• Control group: 5 minutes of non-specific mobilization at a distant thoracic level.

Both groups will receive the same standard physiotherapy care based on exercise and education, delivered over 12 sessions within a 60-day period.

The primary outcome is the Oswestry Disability Index (ODI) score at 26-30 days. Secondary outcomes include pain intensity (Numeric Rating Scale), pain distribution (body diagram), and long-term disability (ODI at 52-60 days). The hypothesis is that the specific, patient-tailored manual therapy will improve functional outcomes and reduce pain more effectively than non-specific mobilization.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastien MARTIN, PT, MSc; Phone Number: +33 0612729653; Email: s.urfamartin@gmail.com
• Study Contact Backup: Name: Romain ARTICO, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specific manual therapy; Usual exercise based physiotherapy + 5 min lumbar PA mobilisations chosen with Algo K algorithm based on symptom response	Procedure: Specific Manual Therapy; 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.
Sham Comparator: Non specific manual therapy; Same physiotherapy + 5 min PA mobilisations in upper thoracic spine, distant from symptoms	Procedure: Non specific Manual Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI, %)	Patient-reported disability (ODI French version)	Baseline day to 26-30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI, %)	Disability at end of follow-up	day 52-60 /or visit 12
Pain intensity (numeric rating scale, 0-10)	Average pain last 24h	Baseline day 26-30 ; day 52-60 /or visit 12
Pain topography (body diagram score)	Distal extension of symptoms	Baseline day 26-30 ; day 52-60 /or visit 12

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: valerie VACHER, DRCI-AP-HP, Saint-Louis Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 5, 2025
• First Submitted That Met QC Criteria: August 5, 2025
• First Posted (Actual): August 12, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Low back pain; Physiotherapy; Decision making; Manual therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: APHP230858; 2024-A01892-45 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No