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CompletedNCT06639880hyperkyphosisUpdated Oct 15, 2024

Thoracic Hyperkyphosis and Low Back Pain

An interventional study of usual care exercise and triple attack protocol in Low Back Pain, sponsored by Noha Khaled Shoukry. Completed at 2 sites in Egypt. Open to male participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Noha Khaled Shoukry · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2023, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

This study was conducted on forty male patients (15 in the control group and 25 in the study group)) with low back pain hyperkyphosis of the thoracic spine, ages ranged from 20 - 40 years old. The visual analogue scale, the Oswestry disability questionnaire, and Cobb's angle was assessed for all patients before any intervention and two months post-intervention.

Read the detailed description

This study was conducted on 40 male patients aged 20 to 40 suffering from LBP. Patients were included in the study if they had hyperkyphosis with an X-ray cobb's angle greater than 40 degrees. The visual analogue scale (VAS), the Oswestry disability questionnaire (ODI), and Cobb's angle were assessed for all patients before and one month post-intervention. Patients who met the inclusion criteria and agreed to participate in this study were randomly assigned to one of the two groups. Group 1 (the control group) received the usual care for the lumbar spine which includes TENS, ultrasound, and myofascial release for the lumbar spine in addition to a core program including bridge, half bridge and clam shell exercise. Group 2 (the study group) received the triple attack protocol which includes a modified P-A mobilization, manipulation, and stabilization program (Active and passive) for the thoracic spine in addition to the usual care and the core program for the lumbar spine

02

Conditions studied

  • Low Back Pain

Keywords

  • hyperkyphosis
  • Cobb's angle
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Noha Khaled Shoukry is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • patients who has low back pain due to facet joint arthropathy or discogenic cause confirmrd by MRI. Chronic spine instability confirmed by clinical tests. Sacroiliac joint confirmed by claster of lattelets. Hyperkyphosis (>40 degree measured by cobb's angle)

Exclusion criteria

Exclusion Criteria:

  • any structural deformity (wedge fracture) or previous spinal surgeries. Spinal tumors or fracture or presence of active infection in the lumbar spine. Systematic disorder (Rheumatoid) Cauda equine lesion, the presence of any comorbidities such as hypertension, DM, hyperlipidemia, obesity, and any autoimmune disease, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    study group

    triple attack protocol which includes a modified P-A mobilization, manipulation, and stabilization program (Active and passive) for the thoracic spine in addition to the usual care and the core program for the lumbar spine

    Other: triple attack protocol

  • Active comparator
    control

    the usual care for the lumbar spine which includes TENS, ultrasound, and myofascial release for the lumbar spine in addition to a core program including bridge, half bridge and clam shell exercise

    Other: usual care exercise

Interventions

  • Otherusual care exercise

    the usual care for the lumbar spine which includes TENS, ultrasound, and myofascial release for the lumbar spine in addition to a core program including bridge, half bridge and clam shell exercise

  • Othertriple attack protocol

    a modified P-A mobilization, manipulation, and stabilization program (Active and passive) for the thoracic spine in addition to the usual care and the core program for the lumbar spine

06

What researchers measure

Primary outcomes

  1. level of percieved pain

    The visual analogue scale used to evaluate level of percieved pain

    Time frame: six weeks

  2. thoracic kyphosis angle

    x-ray cobb's angle used to evaluate the degree of hyper kyphosis of the lumbar spine

    Time frame: six weeks

Secondary outcomes

  1. degree of disability

    the Oswestry disability questionnaire sued to evalute level of functional diability

    Time frame: six weeks

07

Study locations

2 sites
  • Faculty of Physical Therapy
    Giza, 12556, Egypt
  • Faculty of physical Therapy Cairo University
    Giza, 12613, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06639880
Lead sponsor
Noha Khaled Shoukry
Responsible party
Noha Khaled Shoukry (lecturer of Biomechanics, Cairo University) — Sponsor-investigator
First posted
Oct 15, 2024
Start date
Jan 1, 2023
Primary completion
Jan 2, 2024
Completion
Jan 2, 2024
Last update
Oct 15, 2024

Oversight

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

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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