Sub Acute Low Back Pain With Radiating SymptomsALGO-KNCT07118033
Algo K Specific Manual Therapy for Sub Acute Low Back Pain With Radicular Symptoms
A study testing Specific Manual Therapy and Non specific Manual Therapy in people with Sub Acute Low Back Pain With Radiating Symptoms, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sub Acute Low Back Pain With Radiating Symptoms
- What is being tested?
- Specific Manual Therapy and Non specific Manual Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Romain ARTICO, PhD contact
About this study
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
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.
Read the 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.
- Being tested
- Specific Manual Therapy, Non specific Manual Therapy
- Keywords
- Low back pain, Manual therapy, Physiotherapy, Decision making
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Manual TherapyProcedure or surgery
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 TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Specific manual therapy | Experimental | Usual exercise based physiotherapy + 5 min lumbar PA mobilisations chosen with Algo K algorithm based on symptom response Receives: Procedure: Specific Manual Therapy |
| Non specific manual therapy | Sham comparator | Same physiotherapy + 5 min PA mobilisations in upper thoracic spine, distant from symptoms Receives: Procedure: Non specific Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI, %)
Patient-reported disability (ODI French version)
Measured: Baseline day to 26-30
Secondary outcomes (3)
Oswestry Disability Index (ODI, %)
Disability at end of follow-up
Measured: day 52-60 /or visit 12
Pain intensity (numeric rating scale, 0-10)
Average pain last 24h
Measured: Baseline day 26-30 ; day 52-60 /or visit 12
Pain topography (body diagram score)
Distal extension of symptoms
Measured: Baseline day 26-30 ; day 52-60 /or visit 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sub Acute Low Back Pain With Radiating SymptomsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- valerie VACHER, Study chair, DRCI-AP-HP, Saint-Louis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118033
- Sponsor's protocol ID
- APHP230858
- Other IDs
- 2024-A01892-45
- Acronym
- ALGO-K
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07118033
- Acronym / sponsor ID
- ALGO-K / APHP230858
- Keywords
- Low back pain, Manual therapy, Physiotherapy, Decision making
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Specific manual therapy | Experimental | Procedure: Specific Manual TherapyUsual exercise based physiotherapy + 5 min lumbar PA mobilisations chosen with Algo K algorithm based on symptom response |
| Non specific manual therapy | Sham comparator | Procedure: Non specific Manual TherapySame physiotherapy + 5 min PA mobilisations in upper thoracic spine, distant from symptoms |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific Manual TherapyParticipants 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 or surgery | Specific manual therapy |
| Non specific Manual TherapyParticipants 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. | Procedure or surgery | Non specific manual therapy |
Primary outcome
Oswestry Disability Index (ODI, %)
Time frame: Baseline day to 26-30
Patient-reported disability (ODI French version)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain ARTICO, PhD contact
valerie VACHER study chair
DRCI-AP-HP, Saint-Louis Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Specific Manual Therapy and Non specific Manual Therapy in people with Sub Acute Low Back Pain With Radiating Symptoms, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastien MARTIN, PT, MSc (0612729653 ext. +33, s.urfamartin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI, %) (time frame: Baseline day to 26-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.