Contralateral Leg Neuro-dynamic and Spine Mobilization With Leg Movement in Patients With Sciatica

NCT ID: NCT06556823

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-03
• Study Completion Date: 2025-01-10

Brief Summary

The aim of this randomized clinical trial is to find the comparison of CLNDT and SMWLM technique in diabetic and non-diabetic sciatica patients on reducing back pain and improving range of motion of knee

Detailed Description

Sciatica is the broad term describe as radicular pain/ or paresthesia that originate from low back and radiate along sciatic nerve or with associated lumbosacral nerve root. Sciatica may occur unilaterally or bilaterally with or without lower extremity pain, People with sciatica describe sharp aching and radiating leg pain. It may cause neurological problem such as weakness, numbness or hypo-reflexes and in some cases bladder dysfunction may be present. Pain and discomfort in sciatica affect daily life activities such as walking, bending and running adversely which affect the quality of life.

Diabetes mellitus is a chronic hyperglycemic multisystem disorder which is characterized by either genetic or metabolic dysfunction. It is further classified into two categories type 1 diabetes mellitus (T1DM) which is genetic disorder that prevents the pancreatic beta cells to secrete insulin either due to destruction or reduced number of pancreatic beta cells and type 2 diabetes mellitus (T2DM) is a metabolic disorder in which peripheral insulin receptors of the body become resistant to insulin. The underlying pathophysiology of diabetes and lumbar spine disorders shows a strong association between lumbar degeneration and type 2 diabetes as there is increasing end product of toxic glycation, Expression of MMP-2 related to degradation of extracellular matrix and hyperglycemia induced inflammation of disc, although these changes were observed in animals as in human there is still some lacking about its pathophysiology.

Contralateral leg neuro-dynamic technique was introduced by Shacklock on Maitland concept of slump test that with in slump test position contralateral leg pain is reduced by maintaining this position. This technique is use to reduced pain and increase ROM in sciatica patients. Spinal Mobilization with leg movement was developed by Brain Mulligan, in this technique continuous lateral glides was applied on spinous process and performing actively or passively leg movement this technique is also use for sciatica patients to reduce pain and increase ROM.

The Rational of present study is to determine which technique CLNDT or SMWLM is more effective than other for Pain, ROM, and disability in diabetic and non- diabetic patients with sciatica. It will also determine effect of HbA1C level on pain, ROM and Disability on CLNDT and SMWLM techniques in Diabetic patients with sciatica

Conditions

Sciatic Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contralateral Leg Neuro Dynamic+ Conventional PT in Diabetic Population):

The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set.

Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Group Type: EXPERIMENTAL

CLNDT+ Conventional PT in Diabetic Population):

Intervention Type: OTHER

The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

contralateral Leg Neuro Dynamic+ Conventional PT in non Diabetic Population):

The patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set.

Group Type: EXPERIMENTAL

CLNDT+ Conventional PT in non Diabetic Population):

Intervention Type: OTHER

The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Spine Mobilization With Leg Movement+ Conventional PT in Diabetic Population)

the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec.

Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set)

Group Type: EXPERIMENTAL

SMWLM+ Conventional PT in Diabetic Population)

Intervention Type: OTHER

the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Spine Mobilization With Leg Movement+ Conventional PT in non Diabetic Population)

The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec.

Group Type: EXPERIMENTAL

SMWLM+ Conventional PT in non Diabetic Population)

Intervention Type: OTHER

the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Interventions

CLNDT+ Conventional PT in Diabetic Population):

The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Intervention Type: OTHER

CLNDT+ Conventional PT in non Diabetic Population):

The participant will be asked to sit on edge of table with hand behind the back with neutral spine. Then patient will be asked to adopted slump forward thoracic and lumbar spine. Then flex the patient neck passively and extend the patient asymptomatic knee with ankle dorsiflexion passively. Adopt this position for 30 sec and 12 rep will be perform for 3 sets and 4 rep per set. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Intervention Type: OTHER

SMWLM+ Conventional PT in Diabetic Population)

the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Intervention Type: OTHER

SMWLM+ Conventional PT in non Diabetic Population)

the participant will be asked to adopt side-lying position on their un-effected side, at edge of treatment table. Then The therapist will be applying transverse glide at spinous process towards floor. Other Therapist extended with slight abduction of 10 degrees and hip and knee flexed to 45 degrees. The participant will actively move into SLR with other therapist assistance. If participant feel pain, then ask them to breathe deeply and hold position for 3 sec. Conventional therapy includes 1. Tens biphasic mode, 90Hz, 100ms pulse width for 10 min 2. Hot pack for 15 min 3. Bridging Exercises (10 rep x 1 Set with 3 sec hold) 4. Ankle pumps (10 rep x 1 Set).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients having sciatica due to degenerative lumbar spine disorder confirm by Straight leg Rise test and Slump test.
• Patients having unilateral radiating leg pain
• Type 2 Diabetic population with past 3 years' history of Diabetes with HbA1c value 5.7% or above

Exclusion Criteria

• Subject having bilateral leg pain or Cauda equina syndrome
• History of fracture at lumbar spine
• Patient having history of lumbar spine surgery or in symptomatic leg
• Subject having lower extremity vascular disease, Malignancy and pregnant female
• Participant having steroid therapy with in last 6 months.
• Subject having Hip pathologies like hip OA, tendinitis and Bursitis.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

maria Khalid, MSOMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC 01864 Aiman Alam

Identifier Type: -

Identifier Source: org_study_id