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Not yet recruiting NCT07118033

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

No phase Interventional Sub Acute Low Back Pain With Radiating Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Specific Manual Therapy, Non specific Manual Therapy.
Who it may be relevant to
Registry conditions: Sub Acute Low Back Pain With Radiating Symptoms. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Oswestry Disability Index (ODI, %) [Time frame: Baseline day to 26-30]
Secondary outcome measures (3)
  • Oswestry Disability Index (ODI, %) [Time frame: day 52-60 /or visit 12]
  • Pain intensity (numeric rating scale, 0-10) [Time frame: Baseline day 26-30 ; day 52-60 /or visit 12]
  • Pain topography (body diagram score) [Time frame: Baseline day 26-30 ; day 52-60 /or visit 12]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07118033 · APHP230858 · 2024-A01892-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗