Thoracic Hyperkyphosis and Low Back Pain (hyperkyphosis)

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: triple attack protocol; Other: usual care exercise

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12556
    • Faculty of Physical Therapy
  • Giza, Egypt, 12613
    • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of percieved pain	The visual analogue scale used to evaluate level of percieved pain	six weeks
thoracic kyphosis angle	x-ray cobb's angle used to evaluate the degree of hyper kyphosis of the lumbar spine	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of disability	the Oswestry disability questionnaire sued to evalute level of functional diability	six weeks

Collaborators and Investigators

• Sponsor: Noha Khaled Shoukry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 2, 2024
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cobb's angle; hyperkyphosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Cairo University N

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No