Relationship Between Pressure Pain Threshold and Pain Intensity, Affect and Disability in CLBP

NCT ID: NCT04482075

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-01-16

Brief Summary

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The association between pressure pain threshold and different aspects of low back pain has garnered attention over the years. However, since most of such studies in the past employed cross sectional designs, a longitudinal study design with follow-up measurements is required to further investigate this relationship. Studying this relationship will not only offer insights into the phenomenon of pain but may also bring us one step closer to achieving the seemingly insurmountable goal of objectively measuring back pain and its different dimensions.

Detailed Description

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This study is aimed to examine and evaluate the true extent of the relationship between pressure pain threshold (PPT) and different aspects of somatic pain, by studying the interplay between PPT and different variables, and by further exploring the predictive capability of PPT values to estimate pain intensity, pain affect and disability associated with chronic low back pain (CLBP). In order to estimate these dimensions a calculator based on mathematical equations using different predictive models will be developed. This tool (calculator) will take into account PPT reading from the lower back region and some other variables having confounding effects on PPT and pain, and will be able to predict pain intensity, affect and associated disability with reasonable accuracy. Patients with chronic low back pain shall be the target population and shall be recruited through referrals from the medical Out-Patients Department of Institute of Physical Medicine \& Rehabilitation, Dow University of Health Sciences and Department of Rehabilitation Medicine PNS-Shifa Hospital, Karachi, Pakistan after initial screening in accordance with the inclusion and exclusion criteria. Screened patients shall then be briefed about the research project. After explaining the study objectives, procedures, potential benefits and discomforts, written informed consent shall be obtained from the patients. Only upon their agreement shall they become study participants and undergo assessments. The study participants shall receive handouts to document Depression and Anxiety, Pain Intensity, Pain Affect, and Disability. Pressure pain threshold (PPT) shall be measured using a manual Algometer. These measurements shall be followed by a session of physiotherapy treatment, after which Pain Intensity, Pain Affect, and Disability shall be recorded again.

Conditions

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Pain Threshold Low Back Pain Pain Measurement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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SEGMENTAL STABILISATION TRAINING (SST)

Segmental Stabilisation Training is an established treatment technique for chronic low back pain

Group Type OTHER

segmental stability training

Intervention Type OTHER

SEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions.

Interventions

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segmental stability training

SEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult males with low back pain with an age group of 18-50 years.

Exclusion Criteria

1. Individuals having low back pain for less than 3 months.
2. Individuals with specific underlying pathology as the cause of CLBP. (Active oncological disease, Known disc derangement, cauda equina syndrome, spinal trauma i.e. fracture, neuropathy i.e. sciatica or severe root compression, spinal structural deformity, infection, inflammatory joint disease, spinal stenosis, spondylolysis, spondylolisthesis).
3. Individuals having neurological diseases (including central and peripheral diseases); metabolic diseases (i.e. diabetes and hypothyroidism); coagulopathies (i.e. haemophilia).
4. Individuals with fibromyalgia syndrome (FMS); myofascial pain syndrome (MPS); allodynia (stroking hyperalgesia).
5. Individuals suffering from aphasia or suffering from deafness, blindness or muteness.
6. Individuals with skin disease (i.e. psoriasis, scleroderma, leprosy, etc.) or skin lesions (i.e. abrasion/laceration/ bruise) in the low back region.
7. Individuals having oral temperature of 100 F or above.
8. Individuals who have undergone spinal surgery.
9. Individuals scoring 28+ for depression, 20+ for anxiety, 34+ for stress on DASS-21.
10. Individuals in whom prone lying causes significant discomfort (i.e. dyspnoea etc.).
11. Individuals who do not perceive pressure pain below 10 kg/cm2 during PPT testing.
12. Individuals evincing bruising to PPT testing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rasim Ul Hasanat Qureshi, MSPT

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Shahzad Ali Syed, MSAPT

Role: STUDY_DIRECTOR

Dow University of Health Sciences

Locations

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Institute of Physical medicine & Rehabilitation, Dow University of Health Sciences

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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Ul Hasanat R, Syed SA, Rathore FA, Iftikhar S. Development of a tool for objectively measuring somatic pain in the low back region based on a longitudinal diagnostic study conducted in Karachi, Pakistan. BMJ Open. 2023 Mar 16;13(3):e067129. doi: 10.1136/bmjopen-2022-067129.

Reference Type DERIVED
PMID: 36927595 (View on PubMed)

Other Identifiers

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00002

Identifier Type: -

Identifier Source: org_study_id

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