Low Back PainhyperkyphosisNCT06639880
Thoracic Hyperkyphosis and Low Back Pain
A study testing triple attack protocol in people with Low Back Pain, run by Noha Khaled Shoukry at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- triple attack protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2023to 2 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Physical Therapy
Giza, 12556
Faculty of physical Therapy Cairo University
Giza, 12613
About this study
Official title: How Does Thoracic Spine Pathomechanics Disturb Lumbar Spine Mechanics? A Randomized Controlled Trial.
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
- Conditions
- Low Back Pain
- Being tested
- usual care exercise, triple attack protocol
- Keywords
- hyperkyphosis, Cobb's angle
- Medical subject headings
- Low Back Pain, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual care exerciseOther
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
triple attack protocolOther
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
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 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 Receives: Other: triple attack protocol |
| control | Active comparator | 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 Receives: Other: usual care exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of percieved pain
The visual analogue scale used to evaluate level of percieved pain
Measured: six weeks
thoracic kyphosis angle
x-ray cobb's angle used to evaluate the degree of hyper kyphosis of the lumbar spine
Measured: six weeks
Secondary outcomes (1)
degree of disability
the Oswestry disability questionnaire sued to evalute level of functional diability
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2023
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Khaled Shoukry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Khaled Shoukry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639880
- Sponsor's protocol ID
- Cairo University N
- Acronym
- hyperkyphosis
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Thoracic Spine Pathomechanics Disturb Lumbar Spine Mechanics? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06639880
- Acronym / sponsor ID
- hyperkyphosis / Cairo University N
- Conditions
- Low Back Pain
- Keywords
- hyperkyphosis, Cobb's angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Noha Khaled ShoukryUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 15 Oct 2024 (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 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: triple attack protocoltriple 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 |
| control | Active comparator | Other: usual care exercisethe 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| usual care exercisethe 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 | control |
| triple attack protocola 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 | study group |
Primary outcome
level of percieved pain
Time frame: six weeks
The visual analogue scale used to evaluate level of percieved pain
thoracic kyphosis angle
Time frame: six weeks
x-ray cobb's angle used to evaluate the degree of hyper kyphosis of the lumbar spine
1 secondary outcome
degree of disability
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triple attack protocol in people with Low Back Pain, run by Noha Khaled Shoukry at 2 sites in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of percieved pain (time frame: six weeks). The study lists 2 primary outcomes in all. 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 15 Oct 2024.