Effects of “arthoro neuro”, a food for special medical purposes, for the dietary management of back pain with a neuropathic component– a randomized, double blind, placebo-controlled study with parallel design

Effects of “arthoro neuro”, a food for special medical purposes, for the dietary management of back pain with a neuropathic component– a randomized, double blind, placebo-controlled study with parallel design - BTS995/16

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011396

Enrollment

104

Registered

2017-01-27

Start date

2017-02-28

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back pain with a neuropathic component spinal syndrome, Lumbago and neuralgia M54

Interventions

Group 1: 1 capsule arthoro neuro contains B- vitamins and nucleotides per day. One capsule of the study product has to be taken with sufficient water with breakfast over a period of 8 weeks. Group 2:

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Men and women between 18 and 70 years. Subjects suffering from back pain, lasting at least 2 months. Neuropathic pain score > 12 (total score PD-Q). BMI =19 and =35 kg/m2. Mean pain during the last 4 weeks between 2 and 8 (3rd Question of PD-Q).

Exclusion criteria

Exclusion criteria: Rheumatism. Chronic intake of nucleotides or B- vitamins during the last 2 months. Missing confirmation of pain during run- in phase.

Design outcomes

Primary

Measure	Time frame
Change over time of total score of pain questionnaire (PD-QTS) before and after 2 months supplementation with arthoro neuro in comparison to placebo.	—

Secondary

Measure	Time frame
Daily pain (Pain diary 11 point numeric scale) assessed daily in the evening (last 2 weeks be-fore visit will be used for analysis) [paindaily]; 1st Question of PD-Q (actual pain) assessed retrospective during visits [PD-Q1st]; 2nd Question of PD-Q (strongest pain during the past 4 weeks) assessed retrospective during visits [PD-Q2nd]; 3rd Question of PD-Q (mean pain during the past 4 weeks) assessed retrospective during vis-its [PD-Q3rd]; Quality of life (SF-36, health survey with 36 questions.) assessed retrospective during visit 1 and 3.	—

Measure

Time frame

Daily pain (Pain diary 11 point numeric scale) assessed daily in the evening (last 2 weeks be-fore visit will be used for analysis) [paindaily]; 1st Question of PD-Q (actual pain) assessed retrospective during visits [PD-Q1st]; 2nd Question of PD-Q (strongest pain during the past 4 weeks) assessed retrospective during visits [PD-Q2nd]; 3rd Question of PD-Q (mean pain during the past 4 weeks) assessed retrospective during vis-its [PD-Q3rd]; Quality of life (SF-36, health survey with 36 questions.) assessed retrospective during visit 1 and 3.

—

Countries

Germany

Contacts

Public ContactClaudia Reule

BIoTeSys GmbH

bts@biotesys.de0711 3105 71 50

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026