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NCT Number: NCT07118033

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Oswestry Disability Index (ODI, %)

    Time frame: Baseline day to 26-30

    Patient-reported disability (ODI French version)

Secondary outcomes

  1. Oswestry Disability Index (ODI, %)

    Time frame: day 52-60 /or visit 12

    Disability at end of follow-up

  2. Pain intensity (numeric rating scale, 0-10)

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

    Average pain last 24h

  3. Pain topography (body diagram score)

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

    Distal extension of symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Romain ARTICO, PhD

CONTACT

Sebastien MARTIN, PT, MSc

CONTACT

[email protected]

0612729653 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: ALGO-K

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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