ClinicalTrials.gg
CompletedNCT06886334FDTUpdated Oct 29, 2026

Flexion-Distraction Technique

An interventional study of exercise and Cox flexion-distraction therapy in Lumbar Disc Herniation, sponsored by Istanbul Medipol University Hospital. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

Updated Oct 29, 2026Now CompletedFirst site in Turkey (Türkiye)+7 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 121 studies in Intervertebral Disc Displacement with a site in Turkey — 24 open to participants now, 30 under way, none of them phase 3. Intervertebral Disc Displacement · Turkey.

Enrollment
32nd of 86
68 · median 60
Started
2025
with 17 others
No phase
85 of 121
12 open now
Registered
78th of 121
by date
Lead sponsor
3 of 121
Istanbul Medipol University Hospital

Among the 121 studies in Intervertebral Disc Displacement with a site in Turkey, this one is the 32nd largest by enrollment of the 86 interventional ones, is one of 18 that started in 2025, is one of 85 with no phase, and was the 78th registered.

By phase

121 studies; the count open now beside each. This study's row is marked.

No phasethis study85 · 12 open
Observational35 · 12 open
Phase 41 · 0 open

By the year they started

First in 2018; this study’s year is marked. 18 started in 2025.

What they test

Size and results

Median enrollment 60 across the 86 interventional studies, 78 across the 35 observational. Of the 80 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 121 studies in Intervertebral Disc Displacement with a site in Turkey, or all of them as a file.
02

Study summary

This prospective, two-center, non-randomized controlled study compared the effects of conventional physical therapy (CPT) and Cox flexion-distraction therapy (CFT) on pain, lumbar range of motion, disability, and health-related quality of life in patients with lumbar disc herniation (LDH).

The study included adults aged 30-60 years diagnosed with L4-L5 lumbar disc herniation who received treatment at Bursa VM Medical Park Hospital or Nilüfer Spine Health Center in Türkiye. Participants were allocated to treatment groups according to their preferred treatment centers, without randomization.

A total of 68 participants were enrolled, and 66 were included in the final analysis (32 in the CFT group and 34 in the CPT group). Both groups received treatment three times per week for four weeks.

The CPT group received therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), superficial heat application, and home exercises. The CFT group received Cox flexion-distraction therapy, superficial heat application, and home exercises.

Pain intensity was assessed using the Visual Analog Scale (VAS), disability using the Oswestry Disability Index (ODI), lumbar range of motion using a standard goniometer, and health-related quality of life using the Short Form-36 Health Survey (SF-36).

The study evaluated clinical outcomes associated with these two conservative treatment approaches, taking into account the non-randomized nature of treatment allocation.

Read the detailed description

This prospective, two-center, non-randomized controlled study compared the effects of conventional physical therapy (CPT) and Cox flexion-distraction therapy (CFT) on pain, lumbar range of motion, disability, and quality of life in patients with lumbar disc herniation (LDH).

The study was conducted at Bursa VM Medical Park Hospital and Nilüfer Spine Health Center in Türkiye. Participants aged 30-60 years with a diagnosis of L4-L5 lumbar disc herniation were recruited from these two centers.

Treatment allocation was determined by participants' preferred treatment centers rather than by a random allocation procedure. Participants receiving treatment at Bursa VM Medical Park Hospital constituted the conventional physical therapy group, whereas participants treated at Nilüfer Spine Health Center constituted the Cox flexion-distraction therapy group. No individual randomization was performed.

A total of 68 participants were initially enrolled, with 34 participants in each treatment group. The final analysis included 66 participants (32 in the CFT group and 34 in the CPT group).

The conventional physical therapy group received therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), superficial heat application, and home exercises. The Cox flexion-distraction therapy group received Cox flexion-distraction treatment, superficial heat application, and home exercises. Both groups underwent treatment three times per week for four weeks.

Pain intensity was assessed using the Visual Analog Scale (VAS), disability using the Oswestry Disability Index (ODI), health-related quality of life using the Short Form-36 Health Survey (SF-36), and lumbar range of motion using a standard goniometer. Assessments were performed before and after the intervention period.

Statistical analyses included baseline-adjusted analysis of covariance (ANCOVA) to evaluate between-group differences, together with appropriate supplementary non-parametric analyses. The Benjamini-Hochberg false discovery rate procedure was applied to account for multiple comparisons.

The study aimed to evaluate differences in clinical outcomes between Cox flexion-distraction therapy and conventional physical therapy while acknowledging the limitations associated with non-randomized, preference-based treatment allocation.

03

Conditions studied

  • Lumbar Disc Herniation

Keywords

  • Pain
  • Range of Motion
  • Flexion-Distraction Technique
  • Conventional Physical Therapy
04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being between 30-60 years of age
  • Having a diagnosis of L4-L5 lumbar disc herniation
  • Not having undergone surgical intervention
  • Having no cognitive impairment or intellectual disability
  • Providing voluntary participation and written consent

Exclusion criteria

Exclusion Criteria:

  • Having previously undergone surgical operation in the lumbar region
  • Having an oncological diagnosis
  • Pregnancy
  • Presence of severe physical or psychological disorders that would prevent completion of the study
  • Participation in another active physical therapy program
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    Conventional Physical Therapy Group (CPTG)

    Participants treated at Bursa VM Medical Park Hospital received a conventional physical therapy programme comprising therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), hot-pack application, and therapeutic exercises. Therapeutic ultrasound was applied to the right and left sides of the affected lumbar region for 4 min on each side. TENS was administered at a frequency of 100 Hz for 20 min, with the stimulation intensity adjusted to a comfortable sensory level perceived by the participant. A hot pack wrapped in a towel was applied over the lumbar region for 15 min. Participants additionally performed a therapeutic exercise programme including pelvic tilt, hip-flexor stretching, hamstring stretching, cat-camel exercises, bridging, and straight-leg-raise exercises. Each exercise was performed for 10 repetitions. The treatment programme was administered three times per week for four consecutive weeks, resulting in a total of 12 treatment sessions.

    Other: exercise · Other: Cox flexion-distraction therapy

  • Experimental
    Flexion-Distraction Group (Cox Technique) (CTG):

    Participants received Cox flexion-distraction therapy, hot-pack application, and therapeutic exercises. Cox therapy was performed on a specialized table in the prone position for approximately 10 minutes per session. Flexion-distraction was applied in sets of five slow cycles, with 3-5 sets per symptomatic segment and 20-30 seconds of rest between sets. Distraction was progressively adjusted according to patient tolerance. A hot pack was applied to the lumbar region for 15 minutes. Exercises included pelvic tilt, hip-flexor and hamstring stretching, cat-camel, bridging, and straight-leg raises, each performed for 10 repetitions. Treatment was administered three times weekly for four weeks (12 sessions).

    Other: Cox flexion-distraction therapy

Interventions

  • Otherexercise

    Participants in both treatment groups performed the same therapeutic exercise programme, including pelvic tilt, hip-flexor stretching, hamstring stretching, cat-camel exercises, bridging, and straight-leg-raise exercises. Each exercise was performed for 10 repetitions. The programme was administered alongside the group-specific interventions three times per week for four weeks (12 sessions).

  • OtherCox flexion-distraction therapy

    Cox flexion-distraction therapy was performed on a specialized table with participants in the prone position. Controlled flexion-distraction movements were applied to the lumbar spine in sets of five slow cycles, with 3-5 sets per symptomatic segment and 20-30 seconds of rest between sets. The distraction distance was progressively adjusted according to participant tolerance. Each session included approximately 10 minutes of Cox therapy, 15 minutes of hot-pack application, and therapeutic exercises. Treatment was administered three times per week for four weeks (12 sessions).

06

What researchers measure

Primary outcomes

  1. subjective pain

    Measurements will be taken in two ways: Visual Analog Scale (VAS): The VAS scale will be used to assess low back pain in individuals with LDH. Participants will mark their pain level on a 10 cm line, where 0 represents "no pain" and 10 represents "very severe pain".

    Time frame: through study completion, an average of 6 months

  2. range of motion

    Lumbar range of motion (ROM) was assessed using a standard goniometer in six planes: flexion, extension, right and left lateral flexion, and right and left rotation. Measurements were performed according to the positioning described by Norkin and White, and the mean of three consecutive measurements was recorded for each movement. Assessments were conducted at baseline and after the four-week treatment period. ROM was measured in degrees (°).

    Time frame: through study completion, an average of 6 months

Secondary outcomes

  1. Functional capacity

    Functional capacity will be evaluated using the Oswestry Disability Index (ODI). The ODI is a questionnaire scale designed to assess the impact of low back pain on daily life. It consists of 10 items, each scored from 0 to 5. The total score reflects the patient's functional capacity. The ODI is a widely used and highly valid scale for evaluating the functional status of patients with low back pain

    Time frame: through study completion, an average of 6 months

  2. Daily living activities

    Daily living activities will be evaluated using the SF-36 Quality of Life Scale. The SF-36 is a questionnaire designed to assess individuals' overall health status and quality of life, covering both physical and mental health dimensions. It consists of 36 questions, and separate scores are calculated for each dimension. The SF-36 is widely used for quality of life assessment in various populations, and its reliability and validity have been well-established.

    Time frame: through study completion, an average of 6 months

07

Study locations

2 sites
  • Bursa VM Medical Park Hospital
    Bursa, Turkey (Türkiye)
  • Nilüfer Spine Health Center
    Bursa, Turkey (Türkiye)
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in Jan 2026, 9 months.

Of 178 non-industry interventional studies with no phase under Intervertebral Disc Displacement, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 9 months is below that.

Counting every sponsor, half of 191 studies reached it within 12 months; a quarter within 5 and three quarters within 27.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 29, 2026: primary completion Apr 2026 → Jan 2026 and completion May 2026 → Jan 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2025
First posted
Mar 20, 2025
StartActual
Apr 2, 2025
Primary completionActual
Jan 3, 2026was Apr 2026
CompletionActual
Jan 20, 2026was May 2026
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Oct 29, 2026
Sites
2 sites added — first site in Turkey (Türkiye)
Show 2 added (2 Turkey (Türkiye))
  • Bursa VM Medical Park Hospital · Bursa, Turkey (Türkiye)
  • Nilüfer Spine Health Center · Bursa, Turkey (Türkiye)
Oct 29, 2026
Primary completion
Apr 3, 2026→Jan 3, 2026 (actual)
Oct 29, 2026
Study completion
May 1, 2026→Jan 20, 2026 (actual)
Oct 29, 2026
Interventions
Added Cox flexion-distraction therapy; removed mobilization
Oct 29, 2026
Primary outcomes
1 removed, 1 description edited
What changed in the outcomes
  • Removedobjective painTime frame: through study completion, an average of 6 months
  • Descriptionrange of motion: how it is measured was reworded
Oct 29, 2026
Design
Added Not applicable; removed Phase 1·Phase 2
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Not yet recruiting→Completed
    2 sites added — first site in Turkey (Türkiye)
    Show 2 added (2 Turkey (Türkiye))
    • Bursa VM Medical Park Hospital · Bursa, Turkey (Türkiye)
    • Nilüfer Spine Health Center · Bursa, Turkey (Türkiye)
    Primary completion Apr 3, 2026→Jan 3, 2026 (now actual)
    Study completion May 1, 2026→Jan 20, 2026 (now actual)
    Primary outcomes 1 removed, 1 description edited
    What changed in the outcomes
    • Removedobjective painTime frame: through study completion, an average of 6 months
    • Descriptionrange of motion: how it is measured was reworded
    Interventions Added Cox flexion-distraction therapy; removed mobilization
    Design Added Not applicable; removed Phase 1·Phase 2
    + 6 other changes: index terms, identifiers, verification date, oversight details, description and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06886334
Responsible party
gulay karacaoglu (Assistant Professor, Head of Physiotherapy and Rehabilitation Department, Istanbul Medipol University Hospital) — Principal investigator
First posted
Mar 20, 2025
Start date
Apr 2, 2025
Primary completion
Jan 3, 2026
Completion
Jan 20, 2026
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion