## Protocol Section
### Identification Module
**NCT ID:** NCT06427434

**Brief Title:** Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Postnatal Low Back Pain

**Official Title:** Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Low Back Pain in Postnatal Women

#### Organization Study ID Info
**ID:** P.T.REC/012/004494
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Mina Nageib Soliman

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study will be carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women.

**Detailed Description:** In fact, up to 75% of women who suffer from pregnancy-related back pain may continue to have pain after giving birth. Women who experience LBP or pelvic girdle pain (PGP) at 3 months postpartum were found to be at higher risk for persistent or chronic LBP. Of these women, only 6% recover within 6-18 months after giving birth.

A modified lumbar Sustained Natural Apophyseal Glide (SNAG) is an existing Mulligan mobilization technique performed with a combination of joint glide and physiological spinal movement. The glide can be applied to the spinous processes, facets, or unilaterally over the transverse processes while the patient performs the active exercise.

Few studies have been concerned with the effects of modified "SNAGS" on the lumbar spine . So, this study will be done to investigate its effect on low back pain in postnatal women aiming to improve their function to accomplish their daily living activities and reduce the side effects of medical treatment.

### Conditions Module

**Conditions:**

- Low Back Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The participants will be asked to perform strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks.

**Intervention Names:**

- Other: Strengthening and stretching exercises to the back and abdominal muscles

**Label:** Strengthening and stretching exercises

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The participants will receive Modified Sustained Natural Apophyseal Glide on the affected lumbar level for 30 sec three times per week for 4 weeks. In addition to strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks

**Intervention Names:**

- Other: Strengthening and stretching exercises to the back and abdominal muscles

- Other: Modified Lumbar Sustained Natural Apophyseal Glide

**Label:** Modified Lumbar Sustained Natural Apophyseal Glide

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Modified Lumbar Sustained Natural Apophyseal Glide

- Strengthening and stretching exercises

**Description:** Strengthening and stretching exercises to the back and abdominal muscles will be performed for 30 min, three times per week for 4 weeks.

**Name:** Strengthening and stretching exercises to the back and abdominal muscles

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Modified Lumbar Sustained Natural Apophyseal Glide

**Description:** Modified Sustained Natural Apophyseal Glide will be applied on the affected lumbar level for 30 sec three times per week for 4 weeks.

**Name:** Modified Lumbar Sustained Natural Apophyseal Glide

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The visual analogue scale is a 10 cm calibrated line with 0 representing no pain and 10 representing the worst pain; will be used to assess the severity of pain before and after treatment for all participants in both groups.

**Measure:** Pain intenesity

**Time Frame:** within 4 weeks

**Description:** The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).

**Measure:** Lumbar flexion range of motion

**Time Frame:** within 4 weeks

**Description:** The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position.

The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension.

The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1 cm should be considered abnormal).

**Measure:** Lumbar extension range of motion

**Time Frame:** within 4 weeks

**Description:** The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.

**Measure:** Lumbar lateral flexion range of motion

**Time Frame:** within 4 weeks

#### Secondary Outcomes

**Description:** Functional disability will be assessed by the Oswestry Disability Index, it was developed as a clinical valid and reliable assessment tool that would provide an estimate of disability expressed as a percentage score. It is composed of 10 questions and it takes around 5min for a patient to complete. Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2. Scores are stratified into severity: 0-20, minimal disability; 21-40, moderate disability; 41-60, severe disability; 61-80, crippling back pain; 81-100, bed-bound. A low score = low degree of disability, a high score = high degree of disability.

**Measure:** Functional disability

**Time Frame:** within 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. All participants will be diagnosed as chronic postnatal low back pain.
2. Their ages will be ranged from 20 to 35 years old.
3. Their body mass index (BMI) will not exceed 30 kg/m2.
4. All participants have the same social level.
5. All participants have the same lifestyle.
6. Their number of parity will be ranged from 2-4 children.

Exclusion Criteria:

1. Spinal fracture or any other neurological disorders.
2. Lumbar spinal stenosis from lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
3. Women with BMI \> 30 kg/m2.
4. Participants who had pelvic pathology.
5. Skin disease interferes with mobilization application.
6. Gynecological diseases (chronic pelvic pain, uterine prolapse and retroversion flexion of the uterus).

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** karmamedicalcenter@gmail.com

**Name:** Mina soliman, PHD

**Phone:** 01283605551

**Role:** CONTACT

**Contact 2:**

**Email:** drafafmohamed@cu.edu.eg

**Name:** Afaf Botla, Assistant professor

**Phone:** 01283126608

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Cairo University

**Name:** Azza Kassab, professor

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Back Pain

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Low Back Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Misc Info Module

- Version Holder: 2024-05-31
